Clinical trial NCT01428661: Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: tasimelteon
Major Depressive Disorder
MDD
depression
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Vanda Investigational Site
state: California
city: Irvine
country: United States
facility: Vanda Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Vanda Investigational Site
state: California
city: Oakland
country: United States
facility: Vanda Investigational Site
state: California
city: Oceanside
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Vanda Investigational Site
state: California
city: Torrance
country: United States
facility: Vanda Investigational Site
state: California
city: Denver
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Bradenton
country: United States
facility: Vanda Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Vanda Investigational Site
state: Florida
city: Maitland
country: United States
facility: Vanda Investigational Site
state: Florida
city: N. Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Orlando
country: United States
facility: Vanda Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Joliet
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Prairie Village
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Vanda Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Toms River
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Vanda Investigational Site
state: New York
city: Mt. Kisco
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Rochester
country: United States
facility: Vanda Investigational Site
state: New York
city: Staten Island
country: United States
facility: Vanda Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Portland
country: United States
facility: Vanda Investigational Site
state: Oregon
city: Lincoln
country: United States
facility: Vanda Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Vanda Investigational Site
state: Texas
city: Dallas
country: United States
facility: Vanda Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Vanda Investigational Site
state: Utah
city: Seattle
country: United States
facility: Vanda Investigational Site
state: Washington
city: Brown Deer
country: United States
facility: Vanda Investigational Site
state: Wisconsin
Study officials:
References: