Major Depressive Disorder (MDD) MedDRA version: 15.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Lurasidone
Product Code: SM-13496
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 367514-88-3
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lurasidone (20, 40, and 60 mg/day, flexibly dosed) compared to placebo for the treatment of subjects with major depressive disorder (MDD) currently experiencing a major depressive episode (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR]) with mixed features as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) total score.; Secondary Objective: Mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS) total score ? Mean change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score and SDS subscale scores ? Mean change from baseline to endpoint in the Hamilton Rating Scale for Anxiety (HAM-A) total score ? Safety end tolerability ;Primary end point(s): The primary efficacy endpoint is the mean change from baseline to the 6-week study endpoint in MADRS total score.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoint is the mean change from baseline to the 6-week study endpoint in CGI-S score Other secondary endpoints include the following: ? Mean change from baseline to endpoint in the YMRS total score ? Mean change from baseline to endpoint in the SDS total score and SDS subscale scores ? Mean change from baseline to endpoint in the HAM-A total score ? Proportion of subjects who achieve a response, defined as = 50% reduction from baseline on the MADRS total score at endpoint ? Proportion of subjects who achieve a remission, defined as a MADRS total score of = 12 at endpoint ? Proportion of subjects with treatment-emergent mania, assessed by a YMRS total score of = 16 on any two consecutive visits or at the final assessment, or an AE of mania or hypomania The safety objectives of this study include evaluation of the following: ? Proportion of subjects with AEs and SAEs, and discontinuations due to AEs and SAEs ? Vital signs and ECG measurements ? Movement disorders assessed by the AIMS, BARS, and SARS ? Weight and laboratory measures ? Mean change from baseline to endpoint in sexual functioning based on CSFQ total score and CSFQ subscale scores ? Frequency and severity of suicidality using C-SSRS ;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
Russian Federation, Serbia, Ukraine, United Kingdom
Contacts
Public ContactRosemary Brennecke
Worldwide clinical trials
Outcome results
None listed