Major Depressive Disorder, RecurrentPhase 2NCT01554176

Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

A Phase 2 study testing Filorexant in people with Major Depressive Disorder, Recurrent, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 64 years
Conditions the study is for: Major Depressive Disorder, Recurrent
What is being tested?: Filorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: No sites listed yet
Study dates: 18 May 2012to 3 Sep 2013
Phase: Phase 2
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 21 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.

Who cannot join

Current primary psychiatric diagnosis other than major depression;
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
Alcohol or other substance abuse or dependence (excluding nicotine);
Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
Imminent risk of self-harm or of harm to others;
Participant is a psychiatric inpatient;

Show all 15Show fewer

Participant has been on continuous antidepressant treatment for >18 months prior to Screening visit;
Inadequate response to more than 3 adequate antidepressant trials (including the current antidepressant treatment trial) for treatment of the current depressive episode;
Participant ever received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation for treatment of depression;
History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition;
Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic disease;
Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery bypass surgery) within 3 months of study;
History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
Body Mass Index >40 kg/m^2;
Pregnancy, breast-feeding, or expecting to become pregnant.

About this study

Official title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.

Read the detailed description

Participants will continue to take their pretrial antidepressant medication as prescribed throughout the trial. Participants will be randomized in a 1:1 ratio to receive filorexant or placebo for a 6-week treatment period. Following completion of the treatment period, participants will enter a 2-week double-blind run-out period. During the run-out period, participants who received placebo in the 6-week treatment period will continue to receive placebo and participants who received filorexant in the 6-week treatment period will be randomized to receive either filorexant or placebo in a 1:1 ratio.

Conditions: Major Depressive Disorder, Recurrent
Being tested: Filorexant, Placebo
Keywords: Current depressive episode, moderate to severe
Medical subject headings: Depressive Disorder, Major, Recurrence

What participants receive

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

FilorexantDrug
Also called MK-6096
Filorexant, one 10 mg tablet, orally, once daily at bedtime
PlaceboDrug
Placebo, one tablet, orally, once daily at bedtime

Study groups in NCT01554176
Study group	Role	What they receive
Filorexant 10 mg (Treatment Phase)	Experimental	Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks. Receives: Drug: Filorexant
Placebo (Treatment Phase)	Placebo comparator	Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks. Receives: Drug: Placebo
Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)	Experimental	Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Receives: Drug: Filorexant
Filorexant 10 mg/Placebo (Run-out Phase)	Placebo comparator	Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Receives: Drug: Filorexant; Drug: Placebo
Placebo/Placebo (Run-out Phase)	Placebo comparator	Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase. Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Measured: Baseline and Week 6
Number of Participants With an Adverse Event (AE) During Treatment Phase
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.
Measured: Up to Week 6
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.
Measured: Up to Week 6
Number of Participants With an AE During Run-out Phase
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.
Measured: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)
Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.
Measured: From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)

Secondary outcomes (3)

Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item
The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded "reduced sleep." The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Measured: Baseline and Week 6
Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score
The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Measured: Baseline and Week 6
Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6
The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.
Measured: Week 6

Timeline

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

18 May 20123 Sep 2013

First posted14 Mar 2012 (estimated)
Study start18 May 2012
Primary completion3 Sep 2013
Study completion3 Sep 2013

Why it stopped: Low Enrollment

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive Disorder, RecurrentStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01554176
Sponsor's protocol ID: 6096-022
Other IDs: 2011-005200-15
Status last verified: Oct 2018
First submitted: 12 Mar 2012
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Connor KM, Ceesay P, Hutzelmann J, Snavely D, Krystal AD, Trivedi MH, Thase M, Lines C, Herring WJ, Michelson D. Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2017 Aug 1;20(8):613-618. doi: 10.1093/ijnp/pyx033.
PubMed 28582570

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?

Official record

Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingObservational study
Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression
Depressive; Disorder, Major, Single Episode, Major, With Psychotic Symptoms, Depressive; Disorder, Major, Single Episode, Major (Without Psychotic Symptoms)
Recruiting
Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild
RecruitingObservational study
Predictors of Relapse in Major Depressive Disorder (PERFORM-D)
Major Depressive Disorder (MDD)
Active, not recruiting
Recovery in Telling Life Stories
Schizophrenia Disorders, Personality Disorders

All Major Depressive Disorder, Recurrent trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01554176
Acronym / sponsor ID: 6096-022
Conditions: Major Depressive Disorder, Recurrent
Keywords: Current depressive episode, moderate to severe
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low Enrollment
Enrolment: 129 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 18 May 2012 (actual)
Primary completion: 3 Sep 2013 (actual)
Study completion: 3 Sep 2013 (actual)
First posted: 14 Mar 2012 (estimated)
Results: Posted 7 Nov 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Filorexant 10 mg (Treatment Phase)	Experimental	Drug: FilorexantTreatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Placebo (Treatment Phase)	Placebo comparator	Drug: PlaceboTreatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)	Experimental	Drug: FilorexantRun-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Filorexant 10 mg/Placebo (Run-out Phase)	Placebo comparator	Drug: Filorexant, Drug: PlaceboRun-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Placebo/Placebo (Run-out Phase)	Placebo comparator	Drug: PlaceboRun-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.

Who may qualify

Ages: 21 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.

Key exclusion criteria (15 listed)

Current primary psychiatric diagnosis other than major depression;
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
Alcohol or other substance abuse or dependence (excluding nicotine);
Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
Imminent risk of self-harm or of harm to others;

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
FilorexantAlso: MK-6096Filorexant, one 10 mg tablet, orally, once daily at bedtime	Drug	Filorexant 10 mg (Treatment Phase), Filorexant 10 mg/Filorexant 10 mg (Run-out Phase), Filorexant 10 mg/Placebo (Run-out Phase)
PlaceboPlacebo, one tablet, orally, once daily at bedtime	Drug	Filorexant 10 mg/Placebo (Run-out Phase), Placebo (Treatment Phase), Placebo/Placebo (Run-out Phase)

Primary outcome

Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline and Week 6
The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Number of Participants With an Adverse Event (AE) During Treatment Phase
Time frame: Up to Week 6
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase
Time frame: Up to Week 6
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.
Number of Participants With an AE During Run-out Phase
Time frame: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase
Time frame: From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.

3 secondary outcomes

Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score
Time frame: Baseline and Week 6
Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6
Time frame: Week 6

Results and safety

Results posted to the registry on 7 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Filorexant 10 mg (Treatment Phase)	65	57
Placebo (Treatment Phase)	64	59
Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)	0	0
Filorexant 10 mg/Placebo (Run-out Phase)	0	0
Placebo/Placebo (Run-out Phase)	0	0

Primary outcome: Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: score on a scale

Measure	Filorexant 10 mg (Treatment Phase) n = 58	Placebo (Treatment Phase) n = 61
Baseline	30.3 (4.6)	31 (4.3)
Change at Week 6	-11 (9.5)	-10.3 (8.2)

Filorexant 10 mg (Treatment Phase) vs Placebo (Treatment Phase): Difference in least squares means: -0.7 (95% CI -3.8 to 2.5), p = 0.679, cLDA

Population analysed: Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.

Primary outcome: Number of Participants With an Adverse Event (AE) During Treatment Phase

Time frame: Up to Week 6. Number. Unit: Participants

Measure	Filorexant 10 mg (Treatment Phase) n = 64	Placebo (Treatment Phase) n = 64
Value	27	17

Filorexant 10 mg (Treatment Phase) vs Placebo (Treatment Phase): Difference in percentage incidence: 15.6 (95% CI -0.9 to 31.4)

Population analysed: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase

Time frame: Up to Week 6. Number. Unit: Participants

Measure	Filorexant 10 mg (Treatment Phase) n = 64	Placebo (Treatment Phase) n = 64
Value	1	1

Filorexant 10 mg (Treatment Phase) vs Placebo (Treatment Phase): Difference in percentage incidence: 0 (95% CI -7 to 7)

Population analysed: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

Primary outcome: Number of Participants With an AE During Run-out Phase

Time frame: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks). Number. Unit: Participants

Measure	Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) n = 29	Filorexant 10 mg/Placebo (Run-out Phase) n = 28	Placebo/Placebo (Run-out Phase) n = 59
Value	6	3	9

Population analysed: All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Filorexant 10 mg (Treatment Phase)	1 of 64 (1.6%)	13 of 64 (20.3%)	Not reported
Placebo (Treatment Phase)	0 of 64 (0%)	7 of 64 (10.9%)	Not reported
Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)	0 of 29 (0%)	3 of 29 (10.3%)	Not reported
Filorexant 10 mg/Placebo (Run-out Phase)	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
Placebo/Placebo (Run-out Phase)	1 of 59 (1.7%)	1 of 59 (1.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28582570Connor KM, Ceesay P, Hutzelmann J, Snavely D, Krystal AD, Trivedi MH, Thase M, Lines C, Herring WJ, Michelson D. Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2017 Aug 1;20(8):613-618. doi: 10.1093/ijnp/pyx033.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filorexant in people with Major Depressive Disorder, Recurrent, run by Merck Sharp & Dohme LLC.

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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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 7 Nov 2016). 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 Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline and Week 6). The study lists 5 primary outcomes in all. 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 NCT01554176, which also lists 1 linked publication.

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 7 Nov 2018.