Effectiveness of Atypical Versus Conventional Antipsychot... | NCT00237861

Studies
Effectiveness of Atypical Versus Conventional Antipsychotics in Treating Schizophrenia

NCT00237861

Sponsor

Yale University

Status

Completed

Last Update Posted

Jun 6, 2014Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Schizophrenia

Interventions

risperidone
olanzapine
quetiapine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH057292	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2002Actual

Completion Date

Not provided

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2014

Last Update Posted Date

Jun 6, 2014Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

Brief Summary

This study will compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia.

Detailed Description

At seven participating hospitals, acutely exacerbated patients with schizophrenia were randomly assigned to treatment with antipsychotic from the atypical class vs antipsychotic from the conventional class. Medication choice within class, dose, concomitant medications, and other prescribing decisions were left to the community prescriber. Patients were followed for one year after discharge.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Measure	Description	Time Frame
EPS, TD.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hospitalized for schizophrenia

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Scott W Woods, MD	Yale University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone
D000077152	Olanzapine
D000069348	Quetiapine Fumarate

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
risperidone	Drug
olanzapine	Drug
quetiapine	Drug