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

April 16, 2015 updated by: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10035
        • Manhattan Psychiatric Center
      • Orangeburg, New York, United States, 10962
        • Nathan Kline Institute for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: quetiapine
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
Other Names:
  • Seroquel
Drug: quetiapine
Participant will receive 600 mg/day of quetiapine for 8 weeks.
Other Names:
  • 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
Drug: quetiapine
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
Other Names:
  • Seroquel
Drug: quetiapine
Participant will receive 600 mg/day of quetiapine for 8 weeks.
Other Names:
  • Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Psychiatric Center

Collaborators

Nathan Kline Institute for Psychiatric Research

Investigators

  • Principal Investigator: Leslie Citrome, MD, Nathan Kline Institute for Psychiatric Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSQUET0348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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