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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: tasimelteon
Drug: placebo
Enrollment 507
Recruitment Details  
Pre-assignment Details

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subject left country (1); Placebo: sponsor request (1), subject moved (1), IMP schedule (1), subject incarcerated (1), withdrawn after receipt of medical records (1), visit schedule (1)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

Arm/Group Title Tasimelteon Placebo Open Label Tasimelteon
Hide Arm/Group Description 20 mg tasimelteon capsules, PO daily for 8 weeks Placebo capsules, PO daily for 8 weeks 20 mg capsules, PO daily for 52 weeks
Period Title: Double-Masked Phase
Started 254 253 0 [1]
Completed 197 204 0 [1]
Not Completed 57 49 0
Reason Not Completed
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 Title: Open Label Extension
Started 0 [1] 0 [1] 339
Completed 0 [1] 0 [1] 19
Not Completed 0 0 320
Reason Not Completed
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.
Arm/Group Title Tasimelteon Placebo Open Label Tasimelteon Total
Hide Arm/Group Description 20 mg tasimelteon capsules, PO daily for 8 weeks Placebo capsules, PO daily for 8 weeks 20 mg capsules, PO daily for 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 254 253 339 846
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants 253 participants 339 participants 846 participants
43.7  (12.61) 42.0  (12.46) NA [1]   (NA) 42.9  (12.54)
[1]
The 2 phases of the trial are being separated out so the additive total is correct for each phase.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants 253 participants 339 participants 846 participants
NA [1]   (NA) NA [1]   (NA) 44.1  (12.19) 44.1  (12.19)
[1]
The 2 phases of the trial are being separated out so the additive total is correct for each phase.
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 254 participants 253 participants 339 participants 846 participants
Female 161 171 0 332
Male 93 82 0 175
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 254 participants 253 participants 339 participants 846 participants
Female 0 0 222 222
Male 0 0 117 117
1.Primary Outcome
Title Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.
Arm/Group Title Tasimelteon Placebo Open Label Tasimelteon
Hide Arm/Group Description:
20 mg tasimelteon capsules, PO daily for 8 weeks
Placebo capsules, PO daily for 8 weeks
20 mg capsules, PO daily for 52 weeks
Overall Number of Participants Analyzed 249 243 339
Mean (Standard Error)
Unit of Measure: units on a scale
-8.19  (0.45) -7.83  (0.45) -13.6  (0.34)
Time Frame [Not Specified]
Adverse Event Reporting Description One subject randomized to placebo did not take any study drug.
 
Arm/Group Title Tasimelteon Placebo Open Label Tasimelteon
Hide Arm/Group Description 20 mg tasimelteon capsules, PO daily for 8 weeks Placebo capsules, PO daily for 8 weeks 20 mg capsules, PO daily for 52 weeks
All-Cause Mortality
Tasimelteon Placebo Open Label Tasimelteon
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tasimelteon Placebo Open Label Tasimelteon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/254 (0.79%)      3/252 (1.19%)      6/339 (1.77%)    
General disorders       
Non-Cardiac Chest Pain   0/254 (0.00%)  0 1/252 (0.40%)  1 0/339 (0.00%)  0
Chest Pain   0/254 (0.00%)  0 0/252 (0.00%)  0 2/339 (0.59%)  2
Infections and infestations       
Cellulitis   0/254 (0.00%)  0 0/252 (0.00%)  0 1/339 (0.29%)  1
Staphylococcal Infection   0/254 (0.00%)  0 0/252 (0.00%)  0 1/339 (0.29%)  1
Hepatitis A   0/254 (0.00%)  0 0/252 (0.00%)  0 1/339 (0.29%)  1
Hepatitis B   0/254 (0.00%)  0 0/252 (0.00%)  0 1/339 (0.29%)  1
Injury, poisoning and procedural complications       
Cervical Vertebral Fracture   0/254 (0.00%)  0 0/252 (0.00%)  0 1/339 (0.29%)  1
Investigations       
Blood Pressure Increased   0/254 (0.00%)  0 1/252 (0.40%)  1 0/339 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain   1/254 (0.39%)  1 0/252 (0.00%)  0 0/339 (0.00%)  0
Psychiatric disorders       
Suicidal Ideation   0/254 (0.00%)  0 1/252 (0.40%)  1 0/339 (0.00%)  0
Suicide Attempt   1/254 (0.39%)  1 0/252 (0.00%)  0 0/339 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tasimelteon Placebo Open Label Tasimelteon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/254 (14.96%)      53/252 (21.03%)      74/339 (21.83%)    
Gastrointestinal disorders       
Diarrhoea   15/254 (5.91%)  17 13/252 (5.16%)  15 8/339 (2.36%)  12
Dry Mouth   14/254 (5.51%)  15 10/252 (3.97%)  10 7/339 (2.06%)  8
Infections and infestations       
Upper Respitory Tract Infection   9/254 (3.54%)  9 15/252 (5.95%)  17 22/339 (6.49%)  29
Nasopharyngitis   9/254 (3.54%)  9 12/252 (4.76%)  12 27/339 (7.96%)  37
Nervous system disorders       
Headache   29/254 (11.42%)  37 24/252 (9.52%)  31 34/339 (10.03%)  47
Somnolence   17/254 (6.69%)  19 16/252 (6.35%)  19 10/339 (2.95%)  12
Indicates events were collected by systematic assessment
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
Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01428661     History of Changes
Other Study ID Numbers: VP-VEC-162-2301
First Submitted: August 31, 2011
First Posted: September 5, 2011
Results First Submitted: January 6, 2015
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015