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This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000647
Enrollment
Unknown
Registered
2009-09-30
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 Depression

Interventions

Intervention1: lurasidone: 20-60 mg/day flexibly dosed Intervention2: lurasidone: 80-120 mg/day flexibly dosed Control Intervention1: Placebo: 20-120 mg/day Flexibly dosed

Sponsors

Dainippon Sumitomo Pharma America Inc
Lead Sponsor
Quintiles Research India Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Subject is diagnosed with bipolar I disorder, most resent episode depressed Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion criteria

Exclusion criteria: History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization Imminent risk of suicide or injury to self, others, or property

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpointTimepoint: Time Frame: 6 weeks—

Secondary

MeasureTime frame
Mean change from baseline to endpoint (Week 6) in: ? Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) Mean change from baseline to endpoint (Week 6) in: ? Sheehan Disability Scale (SDS) total scoreTimepoint: Time Frame: 6 weeks—

Countries

India

Contacts

Public ContactSuneela Thatte

Quintiles Research (India) Pvt. Ltd.

Sanghamitra.patnaik@quintiles.com07966303340

Outcome results

None listed

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