High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder - Full Text View

Sponsor:	Manhattan Psychiatric Center
Collaborator:	Clinical Research and Evaluation Facility, Rockland Psychiatric Center
Information provided by:	Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00297947

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: quetiapine	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	December 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
600 mg/day quetiapine (Group B): Experimental	Drug: quetiapine Participant will receive 600 mg/day of quetiapine for 8 weeks.
1200 mg/day quetiapine (Group A): Experimental	Drug: quetiapine Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV criteria for chronic schizophrenia or schizoaffective disorder
Sub-optimal treatment-response
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
Age 18-64 years old
Signed informed consent
Patient is in good general medical health

Exclusion criteria:

History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks
History of failure to respond to quetiapine treatment at dosages > 1200 mg daily for 6 contiguous weeks
History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)
Significant recent history of violence or suicidal activity, which required > 4 episodes of PRN anti-agitation medication per week
Mental retardation
Depot antipsychotic within 30 days before randomization
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297947

Contacts

Contact: Sashank Kaushik, MD	646-672-6177	marcskk@omh.state.ny.us
Contact: Theresa Abad, MSN, RN	646-672-6188	manrtla@omh.state.ny.us

Locations

United States, New York
Manhattan Psychiatric Center	Recruiting
New York, New York, United States, 10035
Contact: Sashank Kaushik, MD marcskk@omh.state.ny.us
Sub-Investigator: Saurabh Kaushik, MD
Sub-Investigator: Benedicto Parker, MD
Sub-Investigator: Anzalee Khan, MS
Nathan Kline Institute for Psychiatric Research	Recruiting
Orangeburg, New York, United States, 10962
Contact: Linda Kline kline@nki.rfmh.org

Sponsors and Collaborators

Manhattan Psychiatric Center

Clinical Research and Evaluation Facility, Rockland Psychiatric Center

Investigators

Principal Investigator:	Jean-Pierre Lindenmayer, MD	Manhattan Psychiatric Center
Principal Investigator:	Leslie Citrome, MD	Nathan Kline Institute for Psychiatric Research

More Information

Additional Information:

Quetiapine on Wikipedia This link exits the ClinicalTrials.gov site

NIMH on Schizophrenia This link exits the ClinicalTrials.gov site

Wikipedia on Schizophrenia This link exits the ClinicalTrials.gov site

Publications:

Citrome L. Quetiapine : dose-response relationship in schizophrenia. CNS Drugs. 2008;22(1):69-72. No abstract available.

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.

Responsible Party:	Manhattan Psychiatric Center ( Jean-Pierre Lindenmayer )
Study ID Numbers:	IRUSQUET0348
Study First Received:	February 27, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00297947 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Manhattan Psychiatric Center:

schizophrenia
quetiapine
schizoaffective disorder

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2009