Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder (MAGELLAN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01428661 |
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Recruitment Status :
Completed
First Posted : September 5, 2011
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
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Sponsor:
Vanda Pharmaceuticals
Information provided by (Responsible Party):
Vanda Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: tasimelteon Drug: placebo | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 507 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
Drug Information available for:
Tasimelteon
| Arm | Intervention/treatment |
|---|---|
| Experimental: tasimelteon |
Drug: tasimelteon
20 mg once daily |
| Placebo Comparator: placebo |
Drug: placebo
once daily |
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428661
Locations
| United States, California | |
| Vanda Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| Vanda Investigational Site | |
| Irvine, California, United States, 92617 | |
| Vanda Investigational Site | |
| Los Alamitos, California, United States, 90720 | |
| Vanda Investigational Site | |
| Oakland, California, United States, 94612 | |
| Vanda Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Vanda Investigational Site | |
| San Diego, California, United States, 92102 | |
| Vanda Investigational Site | |
| Sherman Oaks, California, United States, 91403 | |
| Vanda Investigational Site | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Vanda Investigational Site | |
| Denver, Colorado, United States, 80239 | |
| United States, Florida | |
| Vanda Investigational Site | |
| Bradenton, Florida, United States, 34201 | |
| Vanda Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Vanda Investigational Site | |
| Maitland, Florida, United States, 32751 | |
| Vanda Investigational Site | |
| N. Miami, Florida, United States, 33161 | |
| Vanda Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Vanda Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| Vanda Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
| Vanda Investigational Site | |
| Chicago, Illinois, United States, 60640 | |
| Vanda Investigational Site | |
| Joliet, Illinois, United States, 60435 | |
| United States, Kansas | |
| Vanda Investigational Site | |
| Prairie Village, Kansas, United States, 66205 | |
| United States, Maryland | |
| Vanda Investigational Site | |
| Baltimore, Maryland, United States, 21208 | |
| United States, Massachusetts | |
| Vanda Investigational Site | |
| Boston, Massachusetts, United States, 02135 | |
| United States, Nebraska | |
| Vanda Investigational Site | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Vanda Investigational Site | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Vanda Investigational Site | |
| Toms River, New Jersey, United States, 08755 | |
| Vanda Investigational Site | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New York | |
| Vanda Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| Vanda Investigational Site | |
| Mt. Kisco, New York, United States, 10549 | |
| Vanda Investigational Site | |
| New York, New York, United States, 10168 | |
| Vanda Investigational Site | |
| Rochester, New York, United States, 14618 | |
| Vanda Investigational Site | |
| Staten Island, New York, United States, 10312 | |
| United States, Ohio | |
| Vanda Investigational Site | |
| Cincinnati, Ohio, United States, 45267 | |
| Vanda Investigational Site | |
| Dayton, Ohio, United States, 45417 | |
| United States, Oregon | |
| Vanda Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Rhode Island | |
| Vanda Investigational Site | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, Tennessee | |
| Vanda Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Vanda Investigational Site | |
| Austin, Texas, United States, 78731 | |
| Vanda Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| United States, Utah | |
| Vanda Investigational Site | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| Vanda Investigational Site | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Vanda Investigational Site | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Vanda Pharmaceuticals
| Responsible Party: | Vanda Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01428661 |
| Other Study ID Numbers: |
VP-VEC-162-2301 |
| First Posted: | September 5, 2011 Key Record Dates |
| Results First Posted: | June 19, 2015 |
| Last Update Posted: | June 19, 2015 |
| Last Verified: | June 2015 |
Keywords provided by Vanda Pharmaceuticals:
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tasimelteon Major Depressive Disorder MDD depression |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Depressive Disorder, Major |
Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms |