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

Schizophrenia Clinical Trial

— HDQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297947
• Other study ID #: IRUSQUET0348
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 27, 2006
• Last updated: April 16, 2015
• Start date: December 2004
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Manhattan Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia or schizoaffective disorder

2. Sub-optimal treatment-response

3. Total score > 60 on the Positive and Negative Syndrome Scale (PANSS) at baseline of run-in phase and again at baseline of double blind phase

4. Age 18-64 years old

5. Signed informed consent

6. Patient is in good general medical health

Exclusion criteria:

1. History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks

2. History of failure to respond to quetiapine treatment at dosages > 1200 mg daily for 6 contiguous weeks

3. History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)

4. Significant recent history of violence or suicidal activity, which required > 4 episodes of PRN anti-agitation medication per week

5. Mental retardation

6. Depot antipsychotic within 30 days before randomization

7. Significant medical illness requiring frequent dose adjustment or medication changes

Clozapine non-responders are explicitly excluded, as they would be unlikely to show a response in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• quetiapine
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
• quetiapine
Participant will receive 600 mg/day of quetiapine for 8 weeks.

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York
United States	Nathan Kline Institute for Psychiatric Research	Orangeburg	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Psychiatric Center	Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

Citrome L, Jaffe A, Levine J, Lindenmayer JP. Dosing of quetiapine in schizophrenia: how clinical practice differs from registration studies. J Clin Psychiatry. 2005 Dec;66(12):1512-6. Review. — View Citation

Lindenmayer JP, Citrome L, Khan A, Kaushik S, Kaushik S. A randomized, double-blind, parallel-group, fixed-dose, clinical trial of quetiapine at 600 versus 1200 mg/d for patients with treatment-resistant schizophrenia or schizoaffective disorder. J Clin P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		8 weeks	Yes
Secondary	To see if treatment with quetiapine 1200 mg per day will improve total PANSS more robustly than quetiapine 600 mg per day		8 weeks	No

External Links

•   NIMH on Schizophrenia
•   Quetiapine on Wikipedia
•   Wikipedia on Schizophrenia