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

Sumitomo Pharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Lurasidone 80 mg; Drug: Lurasidone 40mg; Drug: Haloperidol 10mg; Drug: Placebo; Drug: Lurasidone 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044044

D1050049

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

356 participants in 5 patient groups, including a placebo group

Lurasidone 20 mg

Experimental group

Description:

Lurasidone 20 mg tablets

Treatment:

Drug: Lurasidone 20 mg

Lurasidone 40 mg

Experimental group

Description:

Lurasidone 40 mg tablets

Treatment:

Drug: Lurasidone 40mg

Lurasidone 80 mg

Experimental group

Description:

Lurasidone 2 40 mg tablets

Treatment:

Drug: Lurasidone 80 mg

Haloperidol 10mg

Active Comparator group

Description:

Haloperidol 10mg tablets

Treatment:

Drug: Haloperidol 10mg

Placebo

Placebo Comparator group

Description:

Matching Placebo to Lurasidone and Haloperidol

Treatment:

Drug: Placebo