uradisone for the treatment of depression disorder
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 15.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-004132-33-GB
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 209
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method