Clinical Trials Register

Summary
EudraCT Number:	2011-005200-15
Sponsor's Protocol Code Number:	6096-022
National Competent Authority:	Norway - NOMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Norway - NOMA

A.2

EudraCT number

2011-005200-15

A.3

Full title of the trial

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.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

For Treatment Augmentation in Patients with Major Depressive Disorder.

A.4.1

Sponsor's protocol code number

6096-022

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.5.2	Functional name of contact point	Kathryn Connor
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United Arab Emirates
B.5.4	Telephone number	1267305-7690
B.5.5	Fax number	1267305-6390
B.5.6	E-mail	kathryn_connor@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MK-6096
D.3.2	Product code	MK-6096
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	[(2R,5R)-5-(5-Fluoro-pyridin-2-yloxymethyl)-2-methyl-piperidin-1-yl]-(5-methyl-2-pyrimidin-2-yl-phenyl)-methanone
D.3.9.2	Current sponsor code	MK-6096
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

depression

E.1.1.1

Medical condition in easily understood language

depression

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10066555
E.1.2	Term	Chronic depression
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

): (1) To evaluate the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on change from baseline to week 6 in MADRS total score. (2) To assess the safety and tolerability of MK-6096 as augmentation therapy for patients with MDD.

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on the following:
1. Change from baseline to week 6 in the MADRS total score excluding the sleep item;
2. Change from baseline to week 6 in the HAM-D Bech subscale score;
3. HAM-D17 remission (HAM-D17 total score ≤ 7) rate at week 6.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Demographic
• Men and women between 21 and < 65 years of age
• Patient is a male or female not of reproductive potential or female of reproductive potential agreeing to use 2 regionally accepted effective non-hormonal forms of contraception (or abstinent)
• Patient's regular bedtime is between 9 PM (21:00) and 1 AM (01:00).
• Patient’s caffeine consumption does not exceed ≤ 5 standard 6 oz cups/day and patient is willing to continue this behavior throughout the study.
• Patient’s alcohol consumption does not exceed 2 drinks/day, at least 3 hr before bedtime, and the patient is willing to continue this behavior throughout the study.
Procedural
• Patient is able to read and operate an electronic diary.
• Patient is at least 75% compliant with completion of the electronic diary (eDiary) during the Screening Period. Patient must complete the eDiary entries for a minimum of 4 days.
Diagnostic
• Primary diagnosis of recurrent MDD, without psychotic features (DSM-IV-TR).
• Duration of the current depressive episode must be at least 2 months but no more that 1 year at screening.
• At screening, patient is has been on an adequate trial of SSRI or SNRI (See Protocol, Table 2-1) for the current depressive episode. For this protocol, an adequate trial of an SSRI/SNRI is defined as at least 5 weeks of treatment with one of the antidepressants listed below, at an adequate dose for at least 3 weeks (see protocol Table 2-1). Adequacy of the trial, based on duration of treatment and dose must be confirmed by the Investigator with the patient’s primary treating clinician.
• Patient can be maintained on current dose of SSRI-SNRI throughout study.
• At Visits 1 and 2, the patient meets HAM-D entry criterion, as specified by Sponsor (blinded) and confirmed by IVRS.

E.4

Principal exclusion criteria

Demographic
• Patient has history of transmeridian travel (across > 3 time zones) or shift work (permanent night shift or rotating day/night shift work) within past 2 wks or will have to travel (across > 3 time zones) at any time during the study.
Diagnostic
• Patient’s current depressive episode is his/her first depressive episode.
• Patient has a current primary diagnosis (ie, a diagnosis designated by the investigator as the primary source of current distress and functional impairment) of an Axis I disorder other than MDD.
• Patient has a lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder, as determined by the investigator. Note that a history of psychotic features in the context of a previous depressive episode is permitted; however psychotic features associated with the current episode are exclusionary.
• Patient has a known or suspected personality dysfunction that could, in the investigator's opinion, interfere with trial participation or efficacy evaluation. A patient with known antisocial or borderline personality disorder should be excluded.
• Patient has a diagnosis of mental retardation, a history of traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease or another form of dementia, or any chronic organic disease of the central nervous system.
• Patient is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., MADRS item 10 > 3 and/or Type 4 or 5 on the C-SSRS) in the past 1 month or suicidal behavior in the past 6 months.
• Patient currently (within the past year) meets criteria for alcohol or other substance abuse or dependence (excluding nicotine), posttraumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), or eating disorder.
• Patient has a positive screening urine drug screen (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.).
Medications and Treatments
• Patient has an inadequate response to up to 3 antidepressant trials for current episode, in the investigator's opinion.
• Patient uses anxiolytic or sedative-hypnotic agents chronically (≥4 times/wk).
• Patient is taking a prohibited medication (see protocol Table 2-2) within the specified washout period and during the study.
• Patient has a history of hypersensitivity or idiosyncratic reaction to more than two pharmacologic classes of drugs, including prescriptions and over-the-counter medications.
Medical
• If female: pregnant, breastfeeding, or expecting to conceive within duration of study
• Patient has a Body Mass Index > 40 kg/m2.
• Patient has a history or current evidence of any clinically significant disease that according to the investigator might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to week 6 in MADRS total score

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks from baseline (randomization) visit

E.5.2

Secondary end point(s)

) 1. Change from baseline to week 6 in the MADRS total score excluding the sleep item;
2. Change from baseline to week 6 in HAM-D Bech subscale score;
3. HAM-D17 remission (HAM-D17 total score ≤ 7) rate at week 6

E.5.2.1

Timepoint(s) of evaluation of this end point

6 weeks from baseline (randomization) visit

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

326

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

326

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patient will continue pre-trial antidepressant medication throughout the trial and following completion of the trial, as prescribed by their primary treating clinician

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-03

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