Major Depressive Disorder With Mixed Features

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, 6-week, Double-blind, Placebo-controlled, Fixed-dose, Parallel Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Lurasidone 20 mg
* Drug: Lurasidone 60 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. Subject is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]). Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050305): Elevated, expansive mood Inflated self-esteem or grandiosity More talkative than usual or pressure to keep talking Flight of ideas or subjective experience that thoughts are racing Increase in energy or goal-directed activity (either socially, at work or school, or sexually) Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline. Exclusion Criteria: Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening Subject answers yes to Suicidal Ideation Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit. Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 20 mg<br> | Drug: Lurasidone 20 mg<br>* Lurasidone 20 mg once daily orally in the evening<br>* Other names: Latuda;|
| Experimental: Lurasidone 60 mg<br> | Drug: Lurasidone 60 mg<br>* Lurasidone 60 mg once daily orally in the evening<br>* Other names: Latuda;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo once daily orally in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS | Mean change from baseline in MADRS total score after 6 weeks of treatment | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S | Global severity assessed by the CGI-S score (depression) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Lurasidone, Latuda