Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder - Full Text View

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: tasimelteon Drug: placebo	Phase 2 Phase 3

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
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Vanda Pharmaceuticals:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the safety and tolerability of tasimelteon to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Compare the impact of treatment with tasimelteon to placebo on sexual functioning and quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
-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 ] [ Designated as safety issue: Yes ]
-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 ] [ Designated as safety issue: Yes ]
To evaluate the efficacy of tasimelteon compared to placebo using MADRS, CGI-S and HAM-A [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: tasimelteon	Drug: tasimelteon 20 mg once daily
Placebo Comparator: placebo	Drug: placebo once daily

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428661

Show 40 Study Locations

Sponsors and Collaborators

Vanda Pharmaceuticals

More Information

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
Last Updated:	March 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanda Pharmaceuticals:

tasimelteon
Major Depressive Disorder
MDD
depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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