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High Dose Quetiapine in Schizophrenia
NCT00297947Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2004
- Primary completion
- Oct 2014
- Countries
- 1
- Sponsor
- Manhattan Psychiatric Center
- Modality
- Small Molecules
- Drugs
- quetiapine
- Conditions
- schizophreniaschizoaffective disorder
01
Overview
Phase 3, randomised, double-blind trial of quetiapine in schizophrenia and schizoaffective disorder (2 arms), sponsored by Manhattan Psychiatric Center. Primary endpoint: Extrapyramidal Symptoms at 8 weeks. Started Dec 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
1200 mg/day quetiapine
High dose quetiapine 1200 mg/day
600 mg/day quetiapine
Standard dose quetiapine 600 mg/day
03
Who it enrols
Patients with chronic schizophrenia or schizoaffective disorder, sub-optimal treatment response, and PANSS total score > 60. Must be non-responders to 600 mg/day Quetiapine during run-in to be randomized.
04
Endpoints
Primary
Extrapyramidal Symptoms
Secondary
Positive and Negative Syndrome Scale
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