A study to evaluate the efficacy 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

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 - RACE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001808

Enrollment

340

Registered

2011-06-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bipolar I Depression

Interventions

Intervention1: Lurasidone: Oral, 20-120 mg Tablets, flexible dose, daily for 6 weeks. Control Intervention1: Placebo: Oral, Equivalent to Lurasidone dosing

Eligibility

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent and is 18 to 75 years of age inclusive. 2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed ( 4 weeks and less than 12 months) without psychotic features. 3. Has a lifetime history of at least one bipolar manic or mixed manic episode. 4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex. 5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study. 6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after 7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion criteria

Exclusion criteria: 1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. 2. Any chronic organic disease of the CNS (other than Bipolar I Disorder). 3. Hospitalization for a manic or mixed episode within the past two months. 4. Used investigational compound within past 6 months. 5. Cinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Design outcomes

Primary

Measure	Time frame
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 ]Timepoint: 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 ]	—

Measure

Time frame

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 ]Timepoint: 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

Measure	Time frame
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 ]Timepoint: Time Frame: 6 weeks	—

Countries

Canada, China, Colombia, Czech Republic, India, Japan, Lithuania, Peru, Slovakia, Ukraine

Contacts

Public ContactSuchela Srivatsa

Quintiles Research India Pvt. Ltd.

shoibal.mukherjee@quintiles.com91-7838652395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026