NCT00297947

High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder

A Randomized, Double-Blind, Parallel-Group, Fixed Dose, Clinical Trial of Quetiapine 600 mg/Day vs 1200 mg/Day for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Manhattan Psychiatric Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.

Detailed description

The study will be conducted at two sites: Manhattan Psychiatric Center (MPC), and the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research/Rockland Psychiatric Center (NKI). A total of 60 patients will be enrolled, 30 at each location. After a screening period of 1 week, all patients will be entering an open label, four-week quetiapine treatment period (run-in phase), during which quetiapine will be titrated to 600 mg PO daily and other adjunctive antipsychotics will be gradually tapered and discontinued. Other concomitant medications such as mood stabilizers will be maintained, if their dose has been stable for the preceding 2 months. Patients not responding to quetiapine treatment at 600 mg PO (defined as reduction of \< 15% change in Positive and Negative Syndrome Scale (PANSS) total score between start of run-in to end of week 4) during the run-in phase, will be eligible to enter the double blind phase. Study baseline will be Day 7 of Week 4 of the run-in phase. Patients qualifying for the double-blind phase will be randomly assigned to either high dose 1200 mg quetiapine daily (Group A) or to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double blind fashion for 8 weeks (Week 1 through Week 8 of double blind phase). Measures of extra-pyramidal side effects, psychopathology, and safety will be conducted throughout the trial.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	quetiapine	Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
DRUG	quetiapine	Participant will receive 600 mg/day of quetiapine for 8 weeks.

Timeline

• Start date: 2004-12-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2006-03-01
• Last updated: 2015-04-17

Locations

2 sites across 1 country: United States