Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

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Sumitomo Pharma

Status and phase

Completed
Phase 3

Conditions

Bipolar Depression

Treatments

Drug: lurasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868959
D1050256
EUDRACT No. 2008-007483-42

Details and patient eligibility

About

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

Enrollment

817 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
  • Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699.

Exclusion criteria

  • Imminent risk of suicide, injury to self or to others, or damage to property
  • Subject has evidence of severe movement disorders.
  • Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

817 participants in 1 patient group

lurasidone
Experimental group
Treatment:
Drug: lurasidone

Trial contacts and locations

151

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Data sourced from clinicaltrials.gov

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