NCT00295412

Brief Summary

The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
Last Updated

February 23, 2006

Status Verified

September 1, 2005

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

SchizophreniaSubstance Use Disorders

Interventions

quetiapine (drug)DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with as schizophrenia spectrum disorder
  • Patients with a comorbid substance use disorder

You may not qualify if:

  • Patients already on quetiapine or clozapine
  • Patients hospitalized or acutely ill
  • Total score lower than 65 on the PANSS
  • Pregnancy
  • Female subjects of childbearing potential without adequate contraception
  • Abnormal liver function (hepatic enzymes more than 3 times the upper normal limits)
  • Any clinically meaningful unstable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious, progressive physical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche Fernand-Seguin

Montreal, Quebec, H1N 3V2, Canada

Location

MeSH Terms

Conditions

SchizophreniaSubstance-Related Disorders

Interventions

Quetiapine FumaratePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Emmanuel Stip, Md, MSc, CSPQ

    Centre de recherche Fernand-Seguin, Hôpital Louis-H Lafontaine, Departement of Psychiatry, Faculty of medicine, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Last Updated

February 23, 2006

Record last verified: 2005-09

Locations

CA(1)