NCT00297947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

9.8 years

First QC Date

February 27, 2006

Last Update Submit

April 16, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaquetiapineschizoaffective disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To see if treatment with quetiapine 1200 mg per day will improve total PANSS more robustly than quetiapine 600 mg per day

    8 weeks

Study Arms (2)

600 mg/day quetiapine (Group B)

EXPERIMENTAL

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

1200 mg/day quetiapine (Group A)

EXPERIMENTAL

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

Interventions

quetiapineDRUG

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

Also known as: Seroquel
1200 mg/day quetiapine (Group A)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related 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. doi: 10.4088/jcp.v66n1203.

    PMID: 16401150BACKGROUND

  • 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 Psychopharmacol. 2011 Apr;31(2):160-8. doi: 10.1097/JCP.0b013e31820f4fe0.

    PMID: 21346616RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jean-Pierre Lindenmayer, MD

    Manhattan Psychiatric Center

    PRINCIPAL INVESTIGATOR

  • Leslie Citrome, MD

    Nathan Kline Institute for Psychiatric Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

December 1, 2004

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(2)