Major Depressive Disorder Clinical Trial
— MAGELLANOfficial 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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Vanda Pharmaceuticals |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A |