High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
Information source: Manhattan Psychiatric Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: quetiapine (Drug); quetiapine (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Manhattan Psychiatric Center Official(s) and/or principal investigator(s):
Jean-Pierre Lindenmayer, MD, Principal Investigator, Affiliation: Manhattan Psychiatric Center
Leslie Citrome, MD, Principal Investigator, Affiliation: Nathan Kline Institute for Psychiatric Research
Overall contact:
Sashank Kaushik, MD, Phone: 646-672-6177, Email: marcskk@omh.state.ny.us
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: To see if treatment with quetiapine 1200 mg per day will improve total PANSS more robustly than quetiapine 600 mg per day
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
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sashank Kaushik, MD, Phone: 646-672-6177, Email: marcskk@omh.state.ny.us
Manhattan Psychiatric Center, New York, New York 10035, United States; Recruiting
Sashank Kaushik, MD, Email: marcskk@omh.state.ny.us
Saurabh Kaushik, MD, Sub-Investigator
Benedicto Parker, MD, Sub-Investigator
Anzalee Khan, MS, Sub-Investigator
Nathan Kline Institute for Psychiatric Research, Orangeburg, New York 10962, United States; Recruiting
Linda Kline, Email: kline@nki.rfmh.org
Additional Information
Quetiapine on Wikipedia NIMH on Schizophrenia Wikipedia on Schizophrenia
Related 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.
Starting date: December 2004
Ending date: March 2009
Last updated: November 5, 2008
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