## Protocol Section
### Identification Module
**NCT ID:** NCT00515879

**Brief Title:** Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia

**Official Title:** D-cycloserine Enhancement of Exposure in Social Phobia

#### Organization Study ID Info
**ID:** R01MH078308
**Link:** https://reporter.nih.gov/quickSearch/R01MH078308
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Boston University Charles River Campus
#### Secondary ID Infos
**ID:** R01MH078308
**Link:** https://reporter.nih.gov/quickSearch/R01MH078308
**Type:** NIH
**ID:** R01MH075889
**Link:** https://reporter.nih.gov/quickSearch/R01MH075889
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-26

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-07-23

**Type:** ESTIMATED

**Results First Submit Date:** 2013-08-02

**Results First Submit QC Date:** 2015-07-20

#### Start Date
**Date:** 2007-12

**Status Verified Date:** 2019-02

#### Study First Post Date
**Date:** 2007-08-14
**Type:** ESTIMATED
**Study First Submit Date:** 2007-08-10
**Study First Submit QC Date:** 2007-08-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston University Charles River Campus

#### Responsible Party

**Investigator Affiliation:** Boston University Charles River Campus

**Investigator Full Name:** Stefan G. Hofmann

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior therapy in treating people with social anxiety disorder.

**Detailed Description:** Social anxiety disorder (SAD) is among the most common psychiatric conditions and is associated with significant distress and dysfunction in social situations. Although treatment with cognitive-behavior therapy (CBT) is known to help remedy SAD, many patients do not respond to this treatment and most do not reach full recovery. In CBT, patients undergo repeated and prolonged exposure practices to feared social situations to learn better ways to deal with anxiety in these settings. Exposure therapy is based on animal models of extinction of conditioned fears, and recent animal research has identified some of the core pathways and neurotransmitters involved in fear extinction. D-cycloserine (DCS) is a drug that appears to facilitate learning and the process of extinction of conditioned fear in both animals and humans. This study will assess the effectiveness of DCS combined with CBT in treating people with SAD.

Participants in this double-blind study will be randomly assigned to an active or control group. All participants will attend 18 study visits at the Center for Anxiety and Related Disorders over a 9-month period. There will be 12 CBT sessions of 90 minutes each and 6 assessment visits. The CBT sessions will help participants to become more comfortable with social situations. During 5 of the CBT sessions, participants will receive a pill containing either DCS or sugar (placebo). Assessment visits will include interviews, self-report questionnaires, and laboratory tests. These visits will occur at Weeks 1, 7, and 12 during treatment and at Months 3, 6, and 9 post-treatment.

### Conditions Module

**Conditions:**

- Social Anxiety Disorder

**Keywords:**

- Generalized subtype

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 169

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive cognitive behavioral therapy plus D-cycloserine

**Intervention Names:**

- Drug: D-cycloserine

- Behavioral: Cognitive behavioral therapy (CBT)

**Label:** CBT plus d-cycloserine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive cognitive behavioral therapy plus pill placebo

**Intervention Names:**

- Behavioral: Cognitive behavioral therapy (CBT)

- Drug: Placebo

**Label:** CBT plus placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CBT plus d-cycloserine

**Description:** 50 mg

**Name:** D-cycloserine

**Other Names:**

- Seromycin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- CBT plus d-cycloserine

- CBT plus placebo

**Description:** CBT sessions aim to help participants become more comfortable with social situations.

**Name:** Cognitive behavioral therapy (CBT)

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- CBT plus placebo

**Description:** Same dosage as active pill

**Name:** Placebo

**Other Names:**

- Sugar pill

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).

**Measure:** Social Phobic Disorders Severity and Change Form

**Time Frame:** Measured at Months 3 (immediately after treatment)

**Description:** The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).

**Measure:** Liebowitz Social Anxiety Scale (LSAS)

**Time Frame:** Measured at Months 3

#### Secondary Outcomes

**Description:** The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety.

**Measure:** Social Phobia and Anxiety Inventory

**Time Frame:** Measured at Months 3, 6, and 9 post-treatment

**Description:** The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100).

**Measure:** Quality of Life Enjoyment and Satisfaction Questionnaire

**Time Frame:** Measured at Months 3, 6, and 9 post-treatment

**Description:** Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment).

**Measure:** Liebowitz Self-Rated Disability Scale

**Time Frame:** Measured at Months 3, 6, and 9 post-treatment

**Description:** The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment).

**Measure:** Range of Impaired Functioning Tool

**Time Frame:** Measured at Months 3, 6, and 9 post-treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
* Total score of greater than or equal to 60 on the LSAS
* Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities

Exclusion Criteria:

* Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
* Eating disorder within the 6 months prior to study entry
* History of organic brain syndrome, mental retardation, or other cognitive dysfunction
* Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
* Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
* Suicidal thoughts
* Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
* Significant personality dysfunction
* Serious medical illness or instability for which hospitalization may be likely within the next year

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Boston University

**State:** Massachusetts

**Zip:** 02215

#### Overall Officials

**Official 1:**

**Affiliation:** Boston University

**Name:** Stefan G. Hofmann, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Massachusetts General Hospital

**Name:** Mark H. Pollack, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Southern Methodist University

**Name:** Jasper A. Smits, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Hofmann SG, Pollack MH, Otto MW. Augmentation treatment of psychotherapy for anxiety disorders with D-cycloserine. CNS Drug Rev. 2006 Fall-Winter;12(3-4):208-17. doi: 10.1111/j.1527-3458.2006.00208.x.

**PMID:** 17227287

**Citation:** Otto MW, Basden SL, Leyro TM, McHugh RK, Hofmann SG. Clinical perspectives on the combination of D-cycloserine and cognitive-behavioral therapy for the treatment of anxiety disorders. CNS Spectr. 2007 Jan;12(1):51-6, 59-61. doi: 10.1017/s1092852900020526.

**PMID:** 17192764

**Citation:** Hofmann SG, Meuret AE, Smits JA, Simon NM, Pollack MH, Eisenmenger K, Shiekh M, Otto MW. Augmentation of exposure therapy with D-cycloserine for social anxiety disorder. Arch Gen Psychiatry. 2006 Mar;63(3):298-304. doi: 10.1001/archpsyc.63.3.298.

**PMID:** 16520435

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000010698

- Term: Phobic Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety Disorder

- ID: M1117

- Name: Phobia, Social

- Relevance: HIGH

- As Found: Social Anxiety Disorder

- ID: M13603

- Name: Phobic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

- ID: D000072861

- Term: Phobia, Social

### Intervention Browse Module - Ancestors

- ID: D000000892

- Term: Anti-Infective Agents, Urinary

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6729

- Name: Cycloserine

- Relevance: HIGH

- As Found: Single Arm Study

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003523

- Term: Cycloserine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** D-cycloserine-augmented CBT

**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy

**ID:** EG000

**Other Num at Risk:** 87

**Serious Number At Risk:** 87

**Title:** D-cycloserine-augmented CBT

**Group ID:** EG001

**Title:** Placebo-augmented CBT

**Description:** Participants will receive placebo augmented cognitive behavioral therapy

**ID:** EG001

**Other Num at Risk:** 82

**Serious Number At Risk:** 82

**Title:** Placebo-augmented CBT

**Frequency Threshold:** 5

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 87

**Group ID:** BG001

**Value:** 82

**Group ID:** BG002

**Value:** 169

**Units:** Participants

### Group

**ID:** BG000

**Title:** D-cycloserine-augmented CBT

**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy

### Group

**ID:** BG001

**Title:** Placebo-augmented CBT

**Description:** Participants will receive placebo augmented cognitive behavioral therapy

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 82

#### Measurement

**Group ID:** BG002

**Value:** 169

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.89

**Value:** 34.6

#### Measurement

**Group ID:** BG001

**Spread:** 8.9

**Value:** 30.5

#### Measurement

**Group ID:** BG002

**Spread:** 8.41

**Value:** 32.55

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 44

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 74

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 43

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 95

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 82

#### Measurement

**Group ID:** BG002

**Value:** 169

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** shofmann@bu.edu
**Organization:** Boston University
**Phone:** 617 353 9233
**Title:** Dr. Stefan G. Hofmann, Ph.D., Professor of Psychology
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.38
- **Spread:** 
- **Upper Limit:** 2.98
- **Value:** 2.68
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.64
- **Spread:** 
- **Upper Limit:** 3.27
- **Value:** 2.95
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.79
- **Spread:** 
- **Upper Limit:** 43.59
- **Value:** 39.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 37.94
- **Spread:** 
- **Upper Limit:** 47.03
- **Value:** 42.44
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 28.585
- **Upper Limit:** 
- **Value:** 71.08
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 30.311
- **Upper Limit:** 
- **Value:** 73.74
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 75
- **Group ID:** OG001
- **Value:** 64
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 32.188
- **Upper Limit:** 
- **Value:** 69.64
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 30.566
- **Upper Limit:** 
- **Value:** 71.97
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 66
- **Group ID:** OG001
- **Value:** 58
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 31.847
- **Upper Limit:** 
- **Value:** 67.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 33.289
- **Upper Limit:** 
- **Value:** 67.74
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 69
- **Group ID:** OG001
- **Value:** 54
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.075
- **Upper Limit:** 
- **Value:** 67.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.00
- **Upper Limit:** 
- **Value:** 67.44
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 76
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.066
- **Upper Limit:** 
- **Value:** 66.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.872
- **Upper Limit:** 
- **Value:** 67.44
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 68
- **Group ID:** OG001
- **Value:** 60
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.063
- **Upper Limit:** 
- **Value:** 67.08
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.761
- **Upper Limit:** 
- **Value:** 69.58
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 67
- **Group ID:** OG001
- **Value:** 54
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.25681
- **Upper Limit:** 
- **Value:** 15.6117
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.79688
- **Upper Limit:** 
- **Value:** 14.0303
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 66
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.03686
- **Upper Limit:** 
- **Value:** 15.5283
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.98470
- **Upper Limit:** 
- **Value:** 14.4977
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 70
- **Group ID:** OG001
- **Value:** 62
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.72461
- **Upper Limit:** 
- **Value:** 15.3269
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.62630
- **Upper Limit:** 
- **Value:** 14.3130
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 69
- **Group ID:** OG001
- **Value:** 59
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.780
- **Upper Limit:** 
- **Value:** 8.5256
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.80841
- **Upper Limit:** 
- **Value:** 8.6667
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 78
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.67730
- **Upper Limit:** 
- **Value:** 8.6143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.82987
- **Upper Limit:** 
- **Value:** 8.5430
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 70
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.80284
- **Upper Limit:** 
- **Value:** 8.6232
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.43957
- **Upper Limit:** 
- **Value:** 7.7458
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 69
- **Group ID:** OG001
- **Value:** 82
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3 (immediately after treatment)
**Title:** Social Phobic Disorders Severity and Change Form
**Type:** PRIMARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** OG000
**Title:** D-cycloserine-augmented CBT
##### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** OG001
**Title:** Placebo-augmented CBT
#### Outcome Measure 2
**Description:** The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3
**Title:** Liebowitz Social Anxiety Scale (LSAS)
**Type:** PRIMARY
**Unit of Measure:** LSAS scores
##### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** OG000
**Title:** D-cycloserine-augmented CBT
##### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** OG001
**Title:** Placebo-augmented CBT
#### Outcome Measure 3
**Description:** The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3, 6, and 9 post-treatment
**Title:** Social Phobia and Anxiety Inventory
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** OG000
**Title:** D-cycloserine-augmented CBT
##### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** OG001
**Title:** Placebo-augmented CBT
#### Outcome Measure 4
**Description:** The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3, 6, and 9 post-treatment
**Title:** Quality of Life Enjoyment and Satisfaction Questionnaire
**Type:** SECONDARY
**Unit of Measure:** percentage of maximum
##### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** OG000
**Title:** D-cycloserine-augmented CBT
##### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** OG001
**Title:** Placebo-augmented CBT
#### Outcome Measure 5
**Description:** Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3, 6, and 9 post-treatment
**Title:** Liebowitz Self-Rated Disability Scale
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants will receive cognitive behavioral therapy plus D-cycloserine

D-cycloserine: 50 mg

Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations.
**ID:** OG000
**Title:** CBT Plus D-cycloserine
##### Group
**Description:** Participants will receive cognitive behavioral therapy plus pill placebo

Cognitive behavioral therapy (CBT): CBT sessions aim to help participants become more comfortable with social situations.

Placebo: Same dosage as active pill
**ID:** OG001
**Title:** CBT Plus Placebo
#### Outcome Measure 6
**Description:** The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points.
**Reporting Status:** POSTED
**Time Frame:** Measured at Months 3, 6, and 9 post-treatment
**Title:** Range of Impaired Functioning Tool
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** OG000
**Title:** D-cycloserine-augmented CBT
##### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** OG001
**Title:** Placebo-augmented CBT
### Participant Flow Module
#### Group
**Description:** Participants will receive D-cycloserine augmented cognitive behavioral therapy
**ID:** FG000
**Title:** D-cycloserine-augmented CBT
#### Group
**Description:** Participants will receive placebo augmented cognitive behavioral therapy
**ID:** FG001
**Title:** Placebo-augmented CBT
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 87
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 82
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 62
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 62
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Pre-Assignment Details:** Study participants underwent a two-step screening evaluation, consisting of 1) telephone screening, and 2) psychiatric assessment and medical history taking with physical examination.
**Recruitment Details:** Prospective participants were recruited between September 2007 and June 2011 through referrals to the three study sites (Boston University \[BU\], Massachusetts General Hospital \[MGH\], and Southern Methodist University \[SMU\]), from other area clinical facilities and programs, and from advertisements.
**Has Results:** True