Phase IIA Study in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: AZD2624; Drug: Olanzapine; Drug: Placebo

• Registration Number: NCT00686998
• Lead Sponsor: AstraZeneca

Brief Summary

This study is designed to assess the effects of AZD 2624 in patients with schizophrenia

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-30
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-04-28
• Results First Submitted QC: 2011-05-31
• Results First Posted: 2011-06-23
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Females of non-childbearing potential
• Diagnosis of Schizophrenia

Exclusion Criteria

• Clinically relevant disease and /or abnormalities.
• Alcohol or substance abuse not in remission
• Enrollment in another investigational study within 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2624	AZD2624	AZD2624 40 mg
Olanzapine	Olanzapine	Olanzapine 15 mg
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline	Baseline, Day 28	PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Rockville, Maryland, United States