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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01428661
First received: August 31, 2011
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: tasimelteon
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

*Tasi: subject left country (1); Placebo: sponsor request (1), subject moved (1), IMP schedule (1), subject incarcerated (1), withdrawn after receipt of medical records (1), visit schedule (1)

**Tasi: surgery (1), visit schedule (3), +UDS (2), IMP schdule (2), prohibited meds (1), withdrew consent (1), sponsor terminated trial (175)


Reporting Groups
  Description
Tasimelteon 20 mg tasimelteon capsules, PO daily for 8 weeks
Placebo Placebo capsules, PO daily for 8 weeks
Open Label Tasimelteon 20 mg capsules, PO daily for 52 weeks

Participant Flow for 2 periods

Period 1:   Double-Masked Phase
    Tasimelteon     Placebo     Open Label Tasimelteon  
STARTED     254     253     0 [1]
COMPLETED     197     204     0 [1]
NOT COMPLETED     57     49     0  
Protocol Violation                 9                 4                 0  
Adverse Event                 13                 4                 0  
Lost to Follow-up                 14                 14                 0  
Withdrawal by Subject                 18                 20                 0  
Lack of Efficacy                 2                 1                 0  
*Various                 1                 6                 0  
[1] Does not apply.

Period 2:   Open Label Extension
    Tasimelteon     Placebo     Open Label Tasimelteon  
STARTED     0 [1]   0 [1]   339  
COMPLETED     0 [1]   0 [1]   19  
NOT COMPLETED     0     0     320  
Protocol Violation                 0                 0                 9  
Adverse Event                 0                 0                 15  
Lost to Follow-up                 0                 0                 38  
Withdrawal by Subject                 0                 0                 49  
Lack of Efficacy                 0                 0                 24  
**Various                 0                 0                 185  
[1] Does not apply.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tasimelteon 20 mg tasimelteon capsules, PO daily for 8 weeks
Placebo Placebo capsules, PO daily for 8 weeks
Open Label Tasimelteon 20 mg capsules, PO daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Tasimelteon     Placebo     Open Label Tasimelteon     Total  
Number of Participants  
[units: participants]
  254     253     339     846  
Age  
[units: years]
Mean (Standard Deviation)
  43.7  (12.61)     42.0  (12.46)     NA  (NA) [1]   42.9  (12.54)  
Age  
[units: years]
Mean (Standard Deviation)
  NA  (NA) [1]   NA  (NA) [1]   44.1  (12.19)     44.1  (12.19)  
Gender  
[units: participants]
       
Female     161     171     0     332  
Male     93     82     0     175  
Gender  
[units: participants]
       
Female     0     0     222     222  
Male     0     0     117     117  
[1] The 2 phases of the trial are being separated out so the additive total is correct for each phase.



  Outcome Measures

1.  Primary:   Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Curt Wolfgang, Ph.D.
Organization: Vanda Pharmaceuticals Inc.
phone: 202-734-3400
e-mail: curt.wolfgang@vandapharma.com


No publications provided


Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01428661     History of Changes
Other Study ID Numbers: VP-VEC-162-2301
Study First Received: August 31, 2011
Results First Received: January 6, 2015
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration