Major Depressive DisorderPhase 2/3MAGELLANNCT01428661

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

A Phase 2/3 study testing tasimelteon in people with Major Depressive Disorder, run by Vanda Pharmaceuticals at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: tasimelteon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 507 participants
Where: 40 sitesUnited States
Study dates: Sep 2011to May 2013
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Vanda Investigational Site
Atlanta, Georgia, 30308
Vanda Investigational Site
Atlanta, Georgia, 30328
Vanda Investigational Site
Austin, Texas, 78731
Vanda Investigational Site
Baltimore, Maryland, 21208
Vanda Investigational Site
Boston, Massachusetts, 02135
Vanda Investigational Site
Bradenton, Florida, 34201
Vanda Investigational Site
Brooklyn, New York, 11235
Vanda Investigational Site
Brown Deer, Wisconsin, 53223
Vanda Investigational Site
Chicago, Illinois, 60640
Vanda Investigational Site
Cincinnati, Ohio, 45267
Vanda Investigational Site
Dallas, Texas, 75231
Vanda Investigational Site
Dayton, Ohio, 45417
Vanda Investigational Site
Denver, Colorado, 80239
Vanda Investigational Site
Garden Grove, California, 92845
Vanda Investigational Site
Irvine, California, 92617
Vanda Investigational Site
Jacksonville, Florida, 32216
Vanda Investigational Site
Joliet, Illinois, 60435
Vanda Investigational Site
Las Vegas, Nevada, 89102
Vanda Investigational Site
Lincoln, Rhode Island, 02865
Vanda Investigational Site
Los Alamitos, California, 90720
Vanda Investigational Site
Maitland, Florida, 32751
Vanda Investigational Site
Memphis, Tennessee, 38119
Vanda Investigational Site
Mount Kisco, New York, 10549
Vanda Investigational Site
New York, New York, 10168
Vanda Investigational Site
North Miami, Florida, 33161
Vanda Investigational Site
Oakland, California, 94612
Vanda Investigational Site
Oceanside, California, 92056
Vanda Investigational Site
Omaha, Nebraska, 68198
Vanda Investigational Site
Orlando, Florida, 32806
Vanda Investigational Site
Portland, Oregon, 97210
Vanda Investigational Site
Prairie Village, Kansas, 66205
Vanda Investigational Site
Rochester, New York, 14618
Vanda Investigational Site
Salt Lake City, Utah, 84106
Vanda Investigational Site
San Diego, California, 92102
Vanda Investigational Site
Seattle, Washington, 98104
Vanda Investigational Site
Sherman Oaks, California, 91403
Vanda Investigational Site
Staten Island, New York, 10312
Vanda Investigational Site
Toms River, New Jersey, 08755
Vanda Investigational Site
Torrance, California, 90502
Vanda Investigational Site
Willingboro, New Jersey, 08046

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Major Depressive Disorder
Being tested: tasimelteon, placebo
Keywords: tasimelteon, Major Depressive Disorder, MDD, depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tasimelteonDrug
20 mg once daily
placeboDrug
once daily

Study groups in NCT01428661
Study group	Role	What they receive
tasimelteon	Experimental	Not described Receives: Drug: tasimelteon
placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011May 2013

First posted5 Sep 2011 (estimated)
Study startSep 2011
Primary completionJan 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01428661
Sponsor's protocol ID: VP-VEC-162-2301
Acronym: MAGELLAN
Status last verified: Jun 2015
First submitted: 31 Aug 2011
Last updated: 19 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01428661
Acronym / sponsor ID: MAGELLAN / VP-VEC-162-2301
Conditions: Major Depressive Disorder
Keywords: tasimelteon, Major Depressive Disorder, MDD, depression
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 507 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Jan 2013 (actual)
Study completion: May 2013 (actual)
First posted: 5 Sep 2011 (estimated)
Results: Posted 19 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
tasimelteon	Experimental	Drug: tasimelteon
placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tasimelteon20 mg once daily	Drug	tasimelteon
placeboonce daily	Drug	placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 19 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tasimelteon	254	197
Placebo	253	204
Open Label Tasimelteon	0	0

Primary outcome: Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)

Time frame: 8 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Tasimelteon n = 249	Placebo n = 243	Open Label Tasimelteon n = 339
Value	-8.19 (0.45)	-7.83 (0.45)	-13.6 (0.34)

Population analysed: The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tasimelteon	2 of 254 (0.8%)	38 of 254 (15%)	Not reported
Placebo	3 of 252 (1.2%)	53 of 252 (21%)	Not reported
Open Label Tasimelteon	6 of 339 (1.8%)	74 of 339 (21.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tasimelteon in people with Major Depressive Disorder, run by Vanda Pharmaceuticals at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01428661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.