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Trial record 49 of 1067 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder (MAGELLAN)

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ClinicalTrials.gov Identifier: NCT01428661
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 5, 2011
Results First Submitted Date  ICMJE January 6, 2015
Results First Posted Date  ICMJE June 19, 2015
Last Update Posted Date June 19, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 8 weeks ]
Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01428661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2011)
  • Compare the safety and tolerability of tasimelteon to placebo [ Time Frame: 8 weeks ]
    • To assess the number of participants with changes in clinical laboratory and ECG data.
    • Recording of adverse events and vital signs.
  • Compare the efficacy of tasimelteon to placebo on circadian rhythms and sleep parameters [ Time Frame: 8 weeks ]
  • Compare the impact of treatment with tasimelteon to placebo on sexual functioning and quality of life [ Time Frame: 8 weeks ]
    -As measured by the Arizona Sexual Experience Scale (ASEX) and Sheehan Disability Scale (SDS).
  • Assess suicidality in subjects taking tasimelteon or placebo [ Time Frame: 8 weeks ]
    -Measured using the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Explore the contribution of genetic factors on efficacy and safety outcomes [ Time Frame: 8 weeks ]
  • To evaluate the efficacy of tasimelteon compared to placebo using MADRS, CGI-S and HAM-A [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Official Title  ICMJE MAGELLAN: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of 20 Mg Tasimelteon Versus Placebo in Adult Subjects With Major Depressive Disorder Followed by a 52-Week Open-Label Extension
Brief Summary The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
Detailed Description

This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive Disorder (MDD).

The study has three phases: the pre-randomization phase, the randomization phase, and an open-label extension phase. The pre-randomization phase comprises a screening visit where subject's initial eligibility will be evaluated. The randomization phase is comprised of an 8-week double-masked segment. Subjects meeting all entry criteria for the study will enter the randomization phase. During this phase, subjects will be asked to take either 20 mg tasimelteon or placebo for 8 weeks in a double-masked fashion. At the end of the 8-week double-masked phase, those subjects who completed the 8-week treatment phase will be offered to enroll into a 52-week open-label extension where each subject will receive daily doses of 20 mg tasimelteon.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: tasimelteon
    20 mg once daily
  • Drug: placebo
    once daily
Study Arms  ICMJE
  • Experimental: tasimelteon
    Intervention: Drug: tasimelteon
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
507
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2011)
500
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;
  • Current episode ≥4 weeks and ≤1 year;
  • CGI-Severity score ≥4 at screening and baseline.

Exclusion Criteria:

  • Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;
  • Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;
  • A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;
  • Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;
  • Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01428661
Other Study ID Numbers  ICMJE VP-VEC-162-2301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vanda Pharmaceuticals
Study Sponsor  ICMJE Vanda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP