DepressionPhase 2NCT00610649

Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)

A Phase 2 study testing MK-8777 in people with Depression, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: MK-8777
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: No sites listed yet
Study dates: 20 Sep 2007to 10 Dec 2008
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Who cannot join

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
donation of blood within 60 days prior to the anticipated first dose of trial medication.

About this study

Official title: Single Center, Randomized, Placebo-Controlled Trial to Establish Maximum Tolerated Dose, Optimal Titration Schedule, Safety, Tolerability, and Pharmacokinetics of Org 26576 in Patients Diagnosed With Major Depressive Disorder (Protocol No. P174001)

Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

Read the detailed description

This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day [BID] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of MK-8777, or placebo. Following titration (3 days per step), participants will be maintained on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see Interventions).

Conditions: Depression
Being tested: MK-8777, Placebo
Keywords: randomized, placebo controlled, maximum tolerated dose
Medical subject headings: Depression

What participants receive

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

MK-8777Drug
Orally administered capsules containing either 50 mg or 100 mg MK-8777.
PlaceboDrug
Orally administered matching placebo capsules.

Study groups in NCT00610649
Study group	Role	What they receive
Part 1: Block A MK-8777	Experimental	Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. Receives: Drug: MK-8777
Part 1: Block A Placebo	Placebo comparator	Participants receive placebo BID for a total of 16 days. Receives: Drug: Placebo
Part 1: Block B MK-8777	Experimental	Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. Receives: Drug: MK-8777
Part 1: Block B Placebo	Placebo comparator	Participants receive placebo BID for a total of 13 days. Receives: Drug: Placebo
Part 1: Block C MK-8777	Experimental	Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. Receives: Drug: MK-8777
Part 1: Block C Placebo	Placebo comparator	Participants receive placebo BID for a total of 10 days. Receives: Drug: Placebo
Part 1: Block D MK-8777	Experimental	Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. Receives: Drug: MK-8777
Part 1: Block D Placebo	Placebo comparator	Participants receive placebo BID for a total of 13 days. Receives: Drug: Placebo
Part 2: MK-8777 200 mg	Experimental	Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. Receives: Drug: MK-8777
Part 2: MK-8777 800 mg	Experimental	Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. Receives: Drug: MK-8777
Part 2: Placebo	Placebo comparator	Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days. Receives: Drug: Placebo

What is being measured

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

Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.
Measured: Up to 7 days following the last dose of study drug (Up to 23 days)
Part 1: Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: Up to 30 days following the last dose of study drug (Up to 46 days)
Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
Measured: Up to the last dose of study drug (Up to 16 days)
Part 2: Number of Participants With AEs
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: Up to 7 days following the last dose of study drug (Up to 35 days)
Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
Measured: Up to the last dose of study drug (Up to 28 days)

Secondary outcomes (2)

Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)
The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.
Measured: Baseline and end of treatment (Up to Day 16)
Part 2: Change From Baseline in the MADRS
The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.
Measured: Baseline and end of treatment (Up to Day 28)

Timeline

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

20 Sep 200710 Dec 2008

First posted8 Feb 2008 (estimated)
Study start20 Sep 2007
Primary completion18 Nov 2008
Study completion10 Dec 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00610649
Sponsor's protocol ID: P05704
Other IDs: 174001
Status last verified: Oct 2018
First submitted: 28 Jan 2008
Last updated: 6 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

Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
PubMed 34510411
Nations KR, Dogterom P, Bursi R, Schipper J, Greenwald S, Zraket D, Gertsik L, Johnstone J, Lee A, Pande Y, Ruigt G, Ereshefsky L. Examination of Org 26576, an AMPA receptor positive allosteric modulator, in patients diagnosed with major depressive disorder: an exploratory, randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2012 Dec;26(12):1525-39. doi: 10.1177/0269881112458728. Epub 2012 Sep 6.
PubMed 22954616

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

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Survivorship

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Randomized, Placebo-Controlled Trial to Establish Maximum Tolerated Dose, Optimal Titration Schedule, Safety, Tolerability, and Pharmacokinetics of Org 26576 in Patients Diagnosed With Major Depressive Disorder (Protocol No. P174001)
ClinicalTrials.gov ID: NCT00610649
Acronym / sponsor ID: P05704
Conditions: Depression
Keywords: randomized, placebo controlled, maximum tolerated dose
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Sep 2007 (actual)
Primary completion: 18 Nov 2008 (actual)
Study completion: 10 Dec 2008 (actual)
First posted: 8 Feb 2008 (estimated)
Results: Posted 2 Jul 2014

Clinical summary

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

Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 11

Arm	Type	Receives
Part 1: Block A MK-8777	Experimental	Drug: MK-8777Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
Part 1: Block A Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID for a total of 16 days.
Part 1: Block B MK-8777	Experimental	Drug: MK-8777Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
Part 1: Block B Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID for a total of 13 days.
Part 1: Block C MK-8777	Experimental	Drug: MK-8777Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
Part 1: Block C Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID for a total of 10 days.
Part 1: Block D MK-8777	Experimental	Drug: MK-8777Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
Part 1: Block D Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID for a total of 13 days.
Part 2: MK-8777 200 mg	Experimental	Drug: MK-8777Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
Part 2: MK-8777 800 mg	Experimental	Drug: MK-8777Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
Part 2: Placebo	Placebo comparator	Drug: PlaceboParticipants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.

Who may qualify

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

Key inclusion criteria (5 listed)

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Key exclusion criteria (7 listed)

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;

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
MK-8777Orally administered capsules containing either 50 mg or 100 mg MK-8777.	Drug	Part 1: Block A MK-8777, Part 1: Block B MK-8777, Part 1: Block C MK-8777, Part 1: Block D MK-8777, Part 2: MK-8777 200 mg, Part 2: MK-8777 800 mg
PlaceboOrally administered matching placebo capsules.	Drug	Part 1: Block A Placebo, Part 1: Block B Placebo, Part 1: Block C Placebo, Part 1: Block D Placebo, Part 2: Placebo

Primary outcome

Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)
Time frame: Up to 7 days following the last dose of study drug (Up to 23 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 30 days following the last dose of study drug (Up to 46 days)
An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug
Time frame: Up to the last dose of study drug (Up to 16 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).
Part 2: Number of Participants With AEs
Time frame: Up to 7 days following the last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug
Time frame: Up to the last dose of study drug (Up to 28 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).

2 secondary outcomes

Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)
Time frame: Baseline and end of treatment (Up to Day 16)
Part 2: Change From Baseline in the MADRS
Time frame: Baseline and end of treatment (Up to Day 28)

Results and safety

Results posted to the registry on 2 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Block A MK-8777	4	3
Part 1: Block A Placebo	2	1
Part 1: Block B MK-8777	4	4
Part 1: Block B Placebo	2	2
Part 1: Block C MK-8777	4	4
Part 1: Block C Placebo	2	2
Part 1: Block D MK-8777	4	4
Part 1: Block D Placebo	2	2
Part 2: MK-8777 200 mg	10	10
Part 2: MK-8777 800 mg	10	9
Part 2: Placebo	10	9

Primary outcome: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)

Time frame: Up to 7 days following the last dose of study drug (Up to 23 days). Number. Unit: participants

Measure	Part 1: Block A MK-8777 n = 4	Part 1: Block A Placebo n = 2	Part 1: Block B MK-8777 n = 4	Part 1: Block B Placebo n = 2	Part 1: Block C MK-8777 n = 4	Part 1: Block C Placebo n = 2	Part 1: Block D MK-8777 n = 4	Part 1: Block D Placebo n = 2
Value	2	0	1	2	4	0	3	2

Population analysed: The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

Primary outcome: Part 1: Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to 30 days following the last dose of study drug (Up to 46 days). Number. Unit: participants

Measure	Part 1: Block A MK-8777 n = 4	Part 1: Block A Placebo n = 2	Part 1: Block B MK-8777 n = 4	Part 1: Block B Placebo n = 2	Part 1: Block C MK-8777 n = 4	Part 1: Block C Placebo n = 2	Part 1: Block D MK-8777 n = 4	Part 1: Block D Placebo n = 2
Value	0	0	0	0	0	0	0	0

Population analysed: The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

Primary outcome: Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug

Time frame: Up to the last dose of study drug (Up to 16 days). Number. Unit: participants

Measure	Part 1: Block A MK-8777 n = 4	Part 1: Block A Placebo n = 2	Part 1: Block B MK-8777 n = 4	Part 1: Block B Placebo n = 2	Part 1: Block C MK-8777 n = 4	Part 1: Block C Placebo n = 2	Part 1: Block D MK-8777 n = 4	Part 1: Block D Placebo n = 2
Value	1	0	0	0	0	0	0	0

Population analysed: The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

Primary outcome: Part 2: Number of Participants With AEs

Time frame: Up to 7 days following the last dose of study drug (Up to 35 days). Number. Unit: participants

Measure	Part 2: MK-8777 200 mg n = 10	Part 2: MK-8777 800 mg n = 10	Part 2: Placebo n = 10
Value	10	9	9

Population analysed: The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Block A MK-8777	0 of 4 (0%)	4 of 4 (100%)	Not reported
Part 1: Block A Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported
Part 1: Block B MK-8777	0 of 4 (0%)	4 of 4 (100%)	Not reported
Part 1: Block B Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported
Part 1: Block C MK-8777	0 of 4 (0%)	4 of 4 (100%)	Not reported
Part 1: Block C Placebo	0 of 2 (0%)	1 of 2 (50%)	Not reported
Part 1: Block D MK-8777	0 of 4 (0%)	4 of 4 (100%)	Not reported
Part 1: Block D Placebo	0 of 2 (0%)	2 of 2 (100%)	Not reported
Part 2: MK-8777 200 mg	0 of 10 (0%)	10 of 10 (100%)	Not reported
Part 2: MK-8777 800 mg	0 of 10 (0%)	9 of 10 (90%)	Not reported
Part 2: Placebo	0 of 10 (0%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34510411Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
Derived from this study: PubMed 22954616Nations KR, Dogterom P, Bursi R, Schipper J, Greenwald S, Zraket D, Gertsik L, Johnstone J, Lee A, Pande Y, Ruigt G, Ereshefsky L. Examination of Org 26576, an AMPA receptor positive allosteric modulator, in patients diagnosed with major depressive disorder: an exploratory, randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2012 Dec;26(12):1525-39. doi: 10.1177/0269881112458728. Epub 2012 Sep 6.
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-8777 in people with Depression, 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 5 inclusion and 7 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 6 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 2 Jul 2014). 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?

Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (time frame: Up to 7 days following the last dose of study drug (Up to 23 days)). 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 NCT00610649, which also lists 2 linked publications.

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 6 Nov 2018.