The purpose of this study is to compare the safety, effectiveness, and tolerability of clozapine and risperidone in patients with first episode schizophrenia and cannabis use disorder.

Condition	Treatment or Intervention	Phase
Schizophrenia Marijuana Abuse	Drug: Risperidone  Drug: Clozapine	Phase II Phase III

Early drug intervention may improve the long-term course of schizophrenia. While clinicians routinely use novel antipsychotics in treating first episode schizophrenia, the novel drug clozapine (CLOZ) is not used clinically because of its side effects and the difficulties associated with its use. CLOZ, however, may be relatively safe and particularly helpful for first episode patients who are comorbid for cannabis use disorder.

Participants in this study are randomly assigned to recieve either CLOZ or risperidone weekly for 1 year. Global functioning, quality of life, and neurocognitive functioning are assessed throughout the study and post-treatment. Clinical rating scales, self report questionnaires, neuropsychological tests, and physical exams are used to assess participants.

Ages Eligible for Study:  17 Years   -   45 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• First episode of schizophrenia and a recent history of cannabis use
• Treatment with an antipsychotic drug at study entry

Exclusion Criteria:

• Medical contraindications to treatment with clozapine or risperidone
• History of seizure disorder or blood dyscrasia
• Pregnancy
• History of substance use disorder with evidence of recent use
• Antipsychotic drug use > 12 weeks
• History of psychosis > 2 years

Massachusetts
      Massachusetts Mental Health Center, Boston,  Massachusetts,  02125,  United States; Recruiting

Study ID Numbers:  62157-01A1
Record last reviewed:  June 2003
Record first received:  June 25, 2003
ClinicalTrials.gov Identifier:  NCT00063349
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08