EUCTR2012-004132-33-GBActive, not recruitingPhase 1
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features (Protocol No D1050304)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 209
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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 Lurasidone Protocol D1050304):
- •o Elevated, expansive mood
- •o Inflated self-esteem or grandiosity
- •o More talkative than usual or pressure to keep talking
- •o Flight of ideas or subjective experience that thoughts are racing
- •o Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
- •o Increased or excessive involvement in activities that have a high potential for painful consequences (eg, engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
- •o 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
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
Investigators
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