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

Major Depressive Disorder Clinical Trial

— MAGELLAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428661
• Other study ID #: VP-VEC-162-2301
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 31, 2011
• Last updated: June 1, 2015
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• tasimelteon
20 mg once daily
• placebo
once daily

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Atlanta	Georgia
United States	Vanda Investigational Site	Atlanta	Georgia
United States	Vanda Investigational Site	Austin	Texas
United States	Vanda Investigational Site	Baltimore	Maryland
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Bradenton	Florida
United States	Vanda Investigational Site	Brooklyn	New York
United States	Vanda Investigational Site	Brown Deer	Wisconsin
United States	Vanda Investigational Site	Chicago	Illinois
United States	Vanda Investigational Site	Cincinnati	Ohio
United States	Vanda Investigational Site	Dallas	Texas
United States	Vanda Investigational Site	Dayton	Ohio
United States	Vanda Investigational Site	Denver	Colorado
United States	Vanda Investigational Site	Garden Grove	California
United States	Vanda Investigational Site	Irvine	California
United States	Vanda Investigational Site	Jacksonville	Florida
United States	Vanda Investigational Site	Joliet	Illinois
United States	Vanda Investigational Site	Las Vegas	Nevada
United States	Vanda Investigational Site	Lincoln	Rhode Island
United States	Vanda Investigational Site	Los Alamitos	California
United States	Vanda Investigational Site	Maitland	Florida
United States	Vanda Investigational Site	Memphis	Tennessee
United States	Vanda Investigational Site	Mt. Kisco	New York
United States	Vanda Investigational Site	N. Miami	Florida
United States	Vanda Investigational Site	New York	New York
United States	Vanda Investigational Site	Oakland	California
United States	Vanda Investigational Site	Oceanside	California
United States	Vanda Investigational Site	Omaha	Nebraska
United States	Vanda Investigational Site	Orlando	Florida
United States	Vanda Investigational Site	Portland	Oregon
United States	Vanda Investigational Site	Prairie Village	Kansas
United States	Vanda Investigational Site	Rochester	New York
United States	Vanda Investigational Site	Salt Lake City	Utah
United States	Vanda Investigational Site	San Diego	California
United States	Vanda Investigational Site	Seattle	Washington
United States	Vanda Investigational Site	Sherman Oaks	California
United States	Vanda Investigational Site	Staten Island	New York
United States	Vanda Investigational Site	Toms River	New Jersey
United States	Vanda Investigational Site	Torrance	California
United States	Vanda Investigational Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)	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.	8 weeks	No