## Protocol Section
### Identification Module
**NCT ID:** NCT00255879

**Brief Title:** Movement Disorders Caused by Antipsychotic Drugs in Older Patients

**Official Title:** Neuroleptic Induced Movement Disorders in Older Patients

#### Organization Study ID Info
**ID:** R01MH059101
**Link:** https://reporter.nih.gov/quickSearch/R01MH059101
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Diego
#### Secondary ID Infos
**ID:** R01MH059101
**Link:** https://reporter.nih.gov/quickSearch/R01MH059101
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2004-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-06-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2004-08

**Type:** ACTUAL

#### Start Date
**Date:** 1999-01

**Status Verified Date:** 2005-11

#### Study First Post Date
**Date:** 2005-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-11-16
**Study First Submit QC Date:** 2005-11-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

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

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Diego

#### Responsible Party

**Investigator Affiliation:** University of California, San Diego

**Investigator Full Name:** Dilip V. Jeste

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.

**Detailed Description:** Use of antipsychotic drugs can result in tardive dyskinesia and extrapyramidal symptoms. Tardive dyskinesia (TD) is a syndrome that causes repetitive, involuntary, purposeless movements in the tongue, lips, or jaw. It can also cause facial grimacing, random movements of arms, legs, fingers, and toes, as well as swaying movements of the trunk or hips. Extrapyramidal symptoms (EPS) include a variety of symptoms, such as involuntary movements, tremors, rigidity, body restlessness, and changes in breathing and heart rate. TD and EPS are side effects of older antipsychotic drugs. Newer antipsychotic drugs, such as quetiapine, olanzapine, and risperidone, do not present as large a risk of developing these side effects. This study will assess the incidence of and risk factors for tardive dyskinesia and extrapyramidal symptoms associated with quetiapine, olanzapine, and risperidone among middle-aged and elderly individuals with psychotic disorders. Additionally, the study will examine the effect of these drugs on symptoms of pre-existing, drug-induced TD. It will also explore the impact of movement disorder symptoms on everyday functioning and quality of life.

Some participants in this open-label study will be randomly assigned to receive quetiapine, olanzapine, or risperidone. Participants who are not randomly assigned to a medication will still receive one of the three medications, based on the decision of their physician. Initial evaluations will be conducted to collect demographic information, as well as medical, psychiatric, and pharmacologic histories. Dosing will be determined by each participant's psychiatrist. All participants will be followed for approximately 5 years. They will report to the study site for outcome assessments at baseline, Months 1 and 3, and every 3 months for the remainder of the study.

### Conditions Module

**Conditions:**

- Dyskinesia, Drug-Induced

**Keywords:**

- Schizophrenia

- Neuroleptic

- Tardive dyskinesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 250

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Quetiapine

**Type:** DRUG

#### Intervention 2

**Name:** Risperidone

**Type:** DRUG

#### Intervention 3

**Name:** Olanzapine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study

**Measure:** Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study

#### Secondary Outcomes

**Measure:** Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study

**Measure:** Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed

Exclusion Criteria:

* N/A

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Diego

**Country:** United States

**Facility:** University of California, San Diego Division of Geriatric Psychiatry

**State:** California

**Zip:** 92161

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Diego

**Name:** Dilip V. Jeste, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000020258

- Term: Neurotoxicity Syndromes

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000011041

- Term: Poisoning

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: HIGH

- As Found: Dyskinesia

- ID: M12029

- Name: Movement Disorders

- Relevance: HIGH

- As Found: Movement Disorders

- ID: M680

- Name: Tardive Dyskinesia

- Relevance: LOW

- As Found: Unknown

- ID: M7583

- Name: Dyskinesia, Drug-Induced

- Relevance: HIGH

- As Found: Dyskinesia, Drug-Induced

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M22080

- Name: Neurotoxicity Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13931

- Name: Poisoning

- Relevance: LOW

- As Found: Unknown

- ID: T4120

- Name: Neurotoxicity Syndromes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020820

- Term: Dyskinesias

- ID: D000009069

- Term: Movement Disorders

- ID: D000004409

- Term: Dyskinesia, Drug-Induced

### Intervention Browse Module - Ancestors

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000017367

- Term: Selective Serotonin Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000000928

- Term: Antidepressive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M20999

- Name: Risperidone

- Relevance: HIGH

- As Found: Evening

- ID: M1675

- Name: Olanzapine

- Relevance: HIGH

- As Found: Tailored

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M399

- Name: Quetiapine Fumarate

- Relevance: HIGH

- As Found: Tip

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19649

- Name: Selective Serotonin Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077152

- Term: Olanzapine

- ID: D000018967

- Term: Risperidone

- ID: D000069348

- Term: Quetiapine Fumarate

### Misc Info Module

- Version Holder: 2024-05-24
