NCT00686998CompletedPhase 2
A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Study Overview
Brief Summary
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Olanzapine
Other
Olanzapine 15 mg
Intervention: Olanzapine (Drug)
AZD2624
Experimental
AZD2624 40 mg
Intervention: AZD2624 (Drug)
Placebo
Placebo Comparator
Matching Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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