First Episode Schizophrenia and Cannabis-Related Disorder Study

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Many individuals with schizophrenia abuse cannabis at the onset of their illness, portending a poorer course of illness and poorer treatment response. Preliminary evidence suggests that clozapine may uniquely reduce substance use in patients with schizophrenia. The purpose of this study is to establish an effective methodology for studying early treatment with clozapine in patients with co-occurring schizophrenia and cannabis use disorder, while generating pilot data comparing clozapine vs. risperidone on substance use, psychiatric symptoms, side effects, and treatment discontinuation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Clozapine; Risperidone

Criteria

Inclusion Criteria:

• Age 17 - 45

• Meets Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder

• Currently within the first episode of schizophrenia ("First Episode" is defined as having onset with the first evidence of psychotic symptoms by history, and the first episode will have ended if the Clinical Global Impressions Scale (CGI) has been < 2 and there has been no rating > 2 on any one of the Brief Psychiatric Rating Scale (BPRS) psychotic items for 6 weeks or longer)

• Meets DSM-IV criteria for cannabis use disorder

• Cannabis use within the five weeks prior to recruitment (screening visit or hospital admission) by self-report (TLFB), collateral report, or drug screen.

• Requires treatment with an antipsychotic medication

• Patients (or guardians) must provide informed consent prior to entry into the study

Exclusion Criteria:

• Medical contraindications to treatment with clozapine or risperidone, including previous paralytic ileus.

• Cumulative treatment with antipsychotic medication in excess of 16 weeks prior to hospital admission (or case identification if an outpatient), unless waived by the Medication Adjustment Group (MAG)

• History of allergic reaction to clozapine or risperidone

• History of seizure disorder or blood dyscrasia. Note: If patients have a history of seizures, but not a diagnosed seizure disorder, they may be admitted to the study if approved by the MAG.

• Current treatment with clozapine

• Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.

• Currently residing in a residential program designed to treat substance use disorders.

• Treatment at baseline with a psychotropic agent proposed to curtail substance use (e.g. disulfiram, naltrexone, valproic acid, topiramate, acamprosate or benzodiazepines) will require a review by the medication adjustment group before entering the client into the study

• Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study (For example, patients who are actively homicidal or have a pending incarceration that would prevent them from participating in the study)

• History of, or current breast cancer

• People who are doing well on current therapy

• Lack of an identifiable primary family/support person, and unable to come to a study site for weekly visits

• Treatment with serotonin re-uptake inhibitors will not be excluded but requires a review by the MAG prior to randomization.

• Patients with current cocaine dependence will require review by the MAG to determine stability for the study.

• Treatment with multiple antipsychotics or long acting injectable antipsychotic at baseline is not excluded, but will be reviewed by the MAG to assess appropriateness for the study.