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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000643
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

None listed

Interventions

Intervention1: Tablet Lurasidone + (lithium or divalproex): 20-120 mg/day Control Intervention1: Matching Placebo + ((lithium or Divalproex): 20-120 mg/day

Sponsors

Dainippon Sumitomo Pharma America Inc
Lead Sponsor
Quintiles Research India Pvt Ltd
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 Subject must be taking lithium or divalproex at least 28 days prior to screening

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

Countries

Saint Kitts and Nevis, South Africa

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