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Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

olanzapine

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill. Patients must have experienced an exacerbation of their illness within the previous 2 weeks. Patients in whom a switch to another antipsychotic medication is acutely indicated. Exclusion Criteria: Patients who are deemed nonresponsive to risperidone or olanzapine. Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1. Patients having received olanzapine or risperidone in the past 30 days. Treatment with clozapine within 1 year prior to Visit 1. Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study). A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Olanzapine for Not Early Onset response (NEO) patients

Risperidone for Not Early Onset response (NEO) patients

Risperidone for Early Onset response (EO) patients

Outcomes

Primary Outcome Measures

Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients

Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).

Secondary Outcome Measures

Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients

The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.

The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.

Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.

Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission

Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups

Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index

Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.

Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants

Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale

Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score

Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score

A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate

Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.

Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure

Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.

Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure

Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate

Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure

Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight

Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.

Full Information

NCT ID

NCT00337662

First Posted

June 14, 2006

Last Updated

February 8, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00337662

Brief Title

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Official Title

Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

628 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Olanzapine for Not Early Onset response (NEO) patients

Arm Title

Arm Type

Active Comparator

Arm Description

Risperidone for Not Early Onset response (NEO) patients

Arm Title

Arm Type

Active Comparator

Arm Description

Risperidone for Early Onset response (EO) patients

Intervention Type

Drug

Intervention Name(s)

olanzapine

Other Intervention Name(s)

LY170053, Zyprexa

Intervention Description

10-20 milligrams (mg), oral, daily, 10 weeks.

Intervention Type

Drug

Intervention Name(s)

risperidone

Intervention Description

2-6 mg, oral, daily, for 10 weeks.

Intervention Type

Drug

Intervention Name(s)

risperidone

Intervention Description

2-6 mg, oral, daily, 10 weeks

Primary Outcome Measure Information:

Title

Description

Time Frame

Weeks 0, 3, 4, 6, 8, 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

Weeks 2, 3, 4, 6, 8, 12

Title

The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score

Description

The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.

Time Frame

Week 0 to Week 12

Title

Description

The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.

Time Frame

Week 0 to Week 12

Title

Description

Time Frame

Week 0 to Week 12

Title

Description

Time Frame

Week 2 to Week 12

Title

Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups

Description

Time Frame

Week 2 to Week 12

Title

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index

Description

Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.

Time Frame

Week 2 to Week 12

Title

Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants

Description

Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.

Time Frame

Week 2 to Week 12

Title

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale

Description

Time Frame

Week 2 to Week 12

Title

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score

Description

Time Frame

Week 2 to Week 12

Title

Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score

Description

Time Frame

Week 2 to Week 12

Title

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate

Description

Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

Title

Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure

Description

Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

Title

Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure

Description

Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

Title

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate

Description

Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

Title

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure

Description

Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

Title

Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight

Description

Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.

Time Frame

Week 2 and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72201

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

City

National City

State/Province

California

ZIP/Postal Code

91950

Country

United States

Facility Name

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68133

Country

United States

Facility Name

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

City

Olean

State/Province

New York

ZIP/Postal Code

14760

Country

United States

Facility Name

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19131

Country

United States

Facility Name

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38117

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78754

Country

United States

Facility Name

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22201

Country

United States

Facility Name

City

Portsmouth

State/Province

Virginia

ZIP/Postal Code

23703

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1062ABF

Country

Argentina

Facility Name

City

Khotkovo

ZIP/Postal Code

127025

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

22204569

Citation

Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.

Results Reference

derived

PubMed Identifier

21813073

Citation

Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12.

Results Reference

derived

PubMed Identifier

20812791

Citation

Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900.

Results Reference

derived

PubMed Identifier

19890258

Citation

Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164.

Results Reference

derived

Learn more about this trial

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

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