High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder (HDQ)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- To see if mean extrapyramidal symptoms measure will change significantly from baseline to endpoint for the whole group and if the mean change in EPS measure is significantly different between quetiapine 1200mg daily group and quetiapine 600mg daily group [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- To see if treatment with quetiapine 1200 mg per day will improve total PANSS more robustly than quetiapine 600 mg per day [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: 600 mg/day quetiapine (Group B)
Patients qualifying for the Double Blind Phase will be randomly assigned to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double-blind fashion for 8 weeks
Participant will receive 600 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel
Experimental: 1200 mg/day quetiapine (Group A)
Patients qualifying for the Double Blind Phase will be randomly assigned to high dose 1200 mg quetiapine daily (Group A) on the assigned dose in a double-blind fashion for 8 weeks
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
Other Name: Seroquel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297947
|United States, New York|
|Manhattan Psychiatric Center|
|New York, New York, United States, 10035|
|Nathan Kline Institute for Psychiatric Research|
|Orangeburg, New York, United States, 10962|
|Principal Investigator:||Jean-Pierre Lindenmayer, MD||Manhattan Psychiatric Center|
|Principal Investigator:||Leslie Citrome, MD||Nathan Kline Institute for Psychiatric Research|