Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)
This study has been completed.
Information provided by (Responsible Party):
First received: January 25, 2011
Last updated: August 29, 2012
Last verified: August 2012
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.
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
Primary Outcome Measures:
- Mean change from baseline in MADRS total score after 6 weeks of treatments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Proportions of subjects with Adverse Events, discontinuations due to Adverse Events and Serious Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Global severity assessed by the CGI-BP-S score (depression) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Functional impairment assessed by the Sheehan Disability Scale (SDS) total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
Experimental: Lurasidone 20-120 mg flexible dose
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Other Name: Latuda
Placebo Comparator: Placebo
Equivalent to Lurasidone dosing
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284517
||Medical Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2011
||August 29, 2012
||United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
China: Ministry of Health
Colombia: National Institutes of Health
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
Peru: Ministry of Health
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health
Keywords provided by Sunovion:
Bipolar I Depression
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Affective Disorders, Psychotic