Trials / Completed
CompletedNCT02731612
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients
A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Lakshmi N Yatham · Academic / Other
- Sex
- All
- Age
- 19 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lurasidone | Atypical Antipsychotic |
| OTHER | Placebo | Inactive substance |
Timeline
- Start date
- 2017-05-08
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2016-04-07
- Last updated
- 2025-02-14
Locations
9 sites across 4 countries: United States, Canada, Japan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02731612. Inclusion in this directory is not an endorsement.