A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride

Criteria

Inclusion criteria:

• The patient has a primary diagnosis of schizophrenia

• The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening

• The patient has had a duration of illness of at least one year.

• The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS

• The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

• The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.

• The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline

• Pregnancy