Major Depressive Disorder With Mixed Features - Extension (RESOLVE3)

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Lurasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423253

D1050306

Details and patient eligibility

About

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion criteria

Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Lurasidone 20, 40, 60 mg

Experimental group

Description:

Lurasidone 20, 40, or 60 mg/day flexibly dosed

Treatment:

Drug: Lurasidone