Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Bipolar Depression

Treatments

Drug: Placebo

Drug: Lurasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01284517

D1050292

2010-019778-34 (EudraCT Number)

Details and patient eligibility

About

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Enrollment

356 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent and is 18 to 75 years of age inclusive.
Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Has a lifetime history of at least one bipolar manic or mixed manic episode.
Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion criteria

Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than Bipolar I Disorder).
Hospitalization for a manic or mixed episode within the past two months.
Used investigational compound within past 6 months.
Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.