Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

• Status: Terminated
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard Medical School; Harvard Medical School (HMS and HSDM)
• Collaborators: Commonwealth Research Center, Massachusetts; Dartmouth-Hitchcock Medical Center; National Institute of Mental Health (NIMH); Novartis
• Treatments: Clozapine; Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• RDC diagnosis of schizophrenia

• Men and women, without regard to race/ethnicity,

• Aged 18-45

• Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of > 21 (on a 0 - 6 scale);

• Require treatment with neuroleptic drugs on a clinical basis;

• The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;

• Be within the first episode of a psychotic disorder;

• Have a history of neuroleptic treatment of < 12 weeks;

• Likely to remain in the study for 2 years.

Exclusion Criteria:

• Substance dependence in the last six months

• History of seizure or blood dyscrasia

• Major medical illness

• Pregnancy or Lactation