## Protocol Section
### Identification Module
**NCT ID:** NCT01234779

**Brief Title:** A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia

**Official Title:** A Phase II, Multi-center, Randomized, 4-week, Double-blind, Parallel Group, Placebo and Active-controlled Trial of the Safety and Efficacy of RO4917838 vs. Placebo in Patients With an Acute Exacerbation of Schizophrenia

#### Organization Study ID Info
**ID:** WN25333
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2010-021984-33
### Status Module
#### Completion Date
**Date:** 2012-09

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2013-10-30

**Type:** ESTIMATED

**Disp First Submit Date:** 2013-10-07
**Disp First Submit QC Date:** 2013-10-07

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-09

**Type:** ACTUAL

#### Start Date
**Date:** 2011-02

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2010-11-04
**Type:** ESTIMATED
**Study First Submit Date:** 2010-11-03
**Study First Submit QC Date:** 2010-11-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.

### Conditions Module

**Conditions:**

- Schizophrenia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 301

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: bitopertin [RO4917838]

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: bitopertin [RO4917838]

**Label:** B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: olanzapine

**Label:** C

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Intervention Names:**

- Drug: placebo

**Label:** D

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** 10 mg orally daily, 4 weeks

**Name:** bitopertin [RO4917838]

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** 30 mg orally daily, 4 weeks

**Name:** bitopertin [RO4917838]

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- C

**Description:** 15 mg orally daily, 4 weeks

**Name:** olanzapine

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- D

**Description:** orally daily, 4 weeks

**Name:** placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Positive and Negative Syndrome Scale (PANSS) total score

**Time Frame:** from baseline to Day 28

**Measure:** Safety: Incidence adverse events

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Measure:** Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score

**Time Frame:** from baseline to Day 28

**Measure:** Change in symptomatology as measured by the PANSS factor and subscale scores

**Time Frame:** from baseline to Day 28

**Measure:** Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale

**Time Frame:** from baseline to Day 28

**Measure:** Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale

**Time Frame:** from baseline to Day 28

**Measure:** Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)

**Time Frame:** from baseline to Day 28

**Measure:** Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)

**Time Frame:** from baseline to Day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients, 18-65 years of age
* Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
* Acute exacerbation which began within the prior 8 weeks
* Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study

Exclusion Criteria:

* Current psychiatric diagnosis other than schizophrenia
* Alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
* Electro-convulsive therapy (ECT) within the prior 6 months
* Previous treatment with RO4917838 or another GLYT inhibitor
* Current treatment with olanzapine, or previous treatment with intolerability or lack of response
* Treatment with long-acting injectable antipsychotic within 2 dosing intervals
* Treatment with \> 2 antipsychotics within 3 months
* History of neuroleptic malignant syndrome
* Have treatment-resistant schizophrenia as judged by treating physician or have failed two trials according to criteria in protocol

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**State:** Arkansas

**Zip:** 72201

**Location 2:**

**City:** Cerritos

**Country:** United States

**State:** California

**Zip:** 90703

**Location 3:**

**City:** Oceanside

**Country:** United States

**State:** California

**Zip:** 92056

**Location 4:**

**City:** Pico Rivera

**Country:** United States

**State:** California

**Zip:** 90660

**Location 5:**

**City:** San Diego

**Country:** United States

**State:** California

**Zip:** 92121

**Location 6:**

**City:** Lauderhill

**Country:** United States

**State:** Florida

**Zip:** 33021

**Location 7:**

**City:** North Miami

**Country:** United States

**State:** Florida

**Zip:** 33161

**Location 8:**

**City:** Atlanta

**Country:** United States

**State:** Georgia

**Zip:** 30308

**Location 9:**

**City:** Lake Charles

**Country:** United States

**State:** Louisiana

**Zip:** 70601

**Location 10:**

**City:** Flowood

**Country:** United States

**State:** Mississippi

**Zip:** 39232

**Location 11:**

**City:** St. Louis

**Country:** United States

**State:** Missouri

**Zip:** 63141

**Location 12:**

**City:** Willingboro

**Country:** United States

**State:** New Jersey

**Zip:** 08046

**Location 13:**

**City:** Holliswood

**Country:** United States

**State:** New York

**Zip:** 11423

**Location 14:**

**City:** New York

**Country:** United States

**State:** New York

**Zip:** 11004

**Location 15:**

**City:** Cincinnati

**Country:** United States

**State:** Ohio

**Zip:** 45219

**Location 16:**

**City:** Philadelphia

**Country:** United States

**State:** Pennsylvania

**Zip:** 19139

**Location 17:**

**City:** Charlesston

**Country:** United States

**State:** South Carolina

**Zip:** 29405

**Location 18:**

**City:** Austin

**Country:** United States

**State:** Texas

**Zip:** 78754

**Location 19:**

**City:** Irving

**Country:** United States

**State:** Texas

**Zip:** 75062

**Location 20:**

**City:** Arad

**Country:** Romania

**Zip:** 310022

**Location 21:**

**City:** Bucuresti

**Country:** Romania

**Zip:** 010825

**Location 22:**

**City:** Bucuresti

**Country:** Romania

**Zip:** 041902

**Location 23:**

**City:** Bucuresti

**Country:** Romania

**Zip:** 041914

**Location 24:**

**City:** Foscani

**Country:** Romania

**Zip:** 620165

**Location 25:**

**City:** Oradea

**Country:** Romania

**Zip:** 410154

**Location 26:**

**City:** Targoviste

**Country:** Romania

**Zip:** 130086

**Location 27:**

**City:** Gatchina

**Country:** Russian Federation

**Zip:** 188357

**Location 28:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 117152

**Location 29:**

**City:** Petrozavodsk

**Country:** Russian Federation

**Zip:** 186131

**Location 30:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 190005

**Location 31:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 193167

**Location 32:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 194044

**Location 33:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 197341

**Location 34:**

**City:** St. Petersburg

**Country:** Russian Federation

**Zip:** 192019

**Location 35:**

**City:** Talagi

**Country:** Russian Federation

**Zip:** 163530

**Location 36:**

**City:** Bojnice

**Country:** Slovakia

**Zip:** 972 01

**Location 37:**

**City:** Bratislava

**Country:** Slovakia

**Zip:** 826 06

**Location 38:**

**City:** Liptovsky Mikulas

**Country:** Slovakia

**Zip:** 3123

**Location 39:**

**City:** Michalovce

**Country:** Slovakia

**Zip:** 071 01

**Location 40:**

**City:** Dnipropetrovsk

**Country:** Ukraine

**Zip:** 49027

**Location 41:**

**City:** Donetsk

**Country:** Ukraine

**Zip:** 83008

**Location 42:**

**City:** Kherson,Vil. Stepanivka

**Country:** Ukraine

**Zip:** 73488

**Location 43:**

**City:** Kyiv

**Country:** Ukraine

**Zip:** 02660

**Location 44:**

**City:** Kyiv

**Country:** Ukraine

**Zip:** 04080

**Location 45:**

**City:** Poltava

**Country:** Ukraine

**Zip:** 36006

**Location 46:**

**City:** Vinnytsya

**Country:** Ukraine

**Zip:** 21005

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

### Intervention Browse Module - Ancestors

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000017367

- Term: Selective Serotonin Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000018490

- Term: Serotonin Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1675

- Name: Olanzapine

- Relevance: HIGH

- As Found: Tailored

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M19649

- Name: Selective Serotonin Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077152

- Term: Olanzapine

### Misc Info Module

- Version Holder: 2024-05-24
