Clinical Trials Register

Summary
EudraCT Number:	2011-006121-26
Sponsor's Protocol Code Number:	40411813DAX2001
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-05-20
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2011-006121-26

A.3

Full title of the trial

A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults with Major Depressive Disorder with Anxiety Symptoms

A.3.1

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

Investigation of the safety, tolerability, and efficacy of JNJ-40411813 as an add-on treatment to an antidepressant in patients with depression with anxiety symptoms

A.4.1

Sponsor's protocol code number

40411813DAX2001

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	Janssen-Cilag International N.V.
B.1.3.4	Country	Belgium
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	Janssen Research and Development, Division of Janssen Pharmaceutica NV
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Janssen Biologics BV - Clinical Registry Group - Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	(+)3171524 21 66
B.5.5	Fax number	(+)3171524 21 10
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	JNJ-40411813-AAA-capsule-25 mg (G029)
D.3.2	Product code	JNJ-40411813-AAA
D.3.4	Pharmaceutical form	Capsule, hard
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	not assigned
D.3.9.2	Current sponsor code	JNJ-40411813-AAA
D.3.9.3	Other descriptive name	R600737
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	25
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.IMP: 2
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	JNJ-40411813-AAA-capsule-50 mg (G025)
D.3.2	Product code	JNJ-40411813-AAA
D.3.4	Pharmaceutical form	Capsule, hard
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	not assigned
D.3.9.2	Current sponsor code	JNJ-40411813-AAA
D.3.9.3	Other descriptive name	R600737
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	50
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	Capsule, hard
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

Major Depressive Disorder with Anxiety Symptoms

E.1.1.1

Medical condition in easily understood language

Depression is a mental disorder characterized by low mood and/or the loss of interest or pleasure in nearly all activities

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	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10025454
E.1.2	Term	Major depressive disorder, recurrent episode
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy, as assessed by the change from baseline on a 6-item subscale derived from the Hamilton Anxiety Scale (HAM-A6), and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.

E.2.2

Secondary objectives of the trial

•Assess impact of adjunctive JNJ-40411813 compared to placebo on anxiety symptoms, assessed by change from baseline on the 14-item Structured Interview Guide for Hamilton Anxiety Scale (total score & response), 17-item Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score, and Inventory of Depressive Symptomatology (IDS-C30) anxiety subscale score; and on change in percentage of subjects meeting criteria for anxious depression.
•Assess impact of adjunctive JNJ-40411813 compared to placebo on depressive symptoms assessed by change from baseline in HDRS17 (total score, response, & remission), HAM-D6 total score, and IDS-C30 total score.
•Assess impact of adjunctive JNJ-40411813 compared to placebo on other clinician & patient-rated assessments of mood, anxiety, sleep, and work productivity.
•Assess for withdrawal symptoms following cessation of JNJ-40411813 with the Physician Withdrawal Checklist.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Be a man or woman 18 to 64 years of age, inclusive.
• Subjects must have a primary DSM-IV diagnosis of MDD. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis (confirmed by independent rater at screening)
• A HDRS17 total score ≥ 18, by independent rater at screening and by the site rater on Day 1.
• A HDRS17 anxiety/somatization factor score ≥ 7, by the independent rater at screening and by the site rater on Day 1.
o HDRS17 anxiety/somatization factor items: Anxiety-psychic, Anxiety-somatic, Loss of Appetite (Somatic Symptoms – Gastrointestinal), Somatic Symptoms – General, Hypochondriasis, Loss of Insight
• Is receiving an antidepressant at an optimal dose and for at least 4 weeks, and no greater than 12 weeks, at Screening.

E.4

Principal exclusion criteria

• Has any other current Axis I psychiatric condition, including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder (eg, bulimia, anorexia nervosa), or schizophrenia. As noted, subjects with a diagnosis of comorbid GAD, Social Anxiety Disorder, or Panic Disorder may be included.
• Has a length of current major depressive episode (MDE) > 6 months
• Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1.
Subjects with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan > 6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the investigator.
• Not including the inadequate response to the current antidepressant, has no more than 1 failed antidepressant treatment of adequate dose and duration in the current major depressive episode.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint for this study will be the improvement in core anxiety symptoms, as measured by the change from baseline in the HAM-A6 score from baseline to the 4-week endpoint for the combined periods in the double-blind treatment phase (see Statistical Methods, Efficacy Analyses).

E.5.1.1

Timepoint(s) of evaluation of this end point

4 weeks

E.5.2

Secondary end point(s)

• The change from baseline to the 4-week endpoint for the combined periods in the double-blind treatment phase for: HDRS17 total score, HDRS17 anxiety-somatization factor total score, HAM-D6 total score, IDS-C30 total score, IDS-C30 anxiety subscale score, Work Limitations Questionnaire (WLQ), Perceived Stress Scale (PSS), Profile of Mood States-Brief Form (POMS-BF), Medical Outcomes Study- Sleep Scale Acute - Revised (MOS Sleep-R), SIGH-A total score, and the Clinical Global Impression – Improvement (CGI-I) value
• The distribution of those meeting criteria for anxious depression, defined as the number and percentage of subjects with a HDRS17 anxiety/somatization factor score ≥ 7.
• The distribution of responders (based on two definitions) and remitters on depressive symptoms as assessed on the HDRS17 at the 4-week endpoint for the combined periods in the double-blind treatment phase, defined as the number and percentage of subjects that are responders (either ≥ 50% or ≥ 30% improvement on HDRS17 total score from baseline) and that are in remission (HDRS17 total score ≤ 7).
• The distribution of responders as assessed on the SIGH-A at the 4-week endpoint for the combined periods in the double-blind treatment phase, defined as the number and percentage of subjects that are responders ( ≥ 50% improvement on SIGH-A total score from baseline).

E.5.2.1

Timepoint(s) of evaluation of this end point

4 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers

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.8.2.4

Number of treatment arms in the trial

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.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Bulgaria

Hungary

Moldova, Republic of

Romania

Russian Federation

Slovakia

Ukraine

E.8.7

Trial has a data monitoring committee

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

LPLV

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 years

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:

120

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.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

120

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)

At the end of the double blind treatment phase (8 weeks), all subjects will discontinue adjunctive study treatment, but will continue taking their baseline antidepressant. In the case the investigator decides not to continue treatment with the antidepressant, the Investigator will provide the subject with the appropriate taper instructions and care, as required.

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

2013-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-05

P. End of Trial
P.	End of Trial Status	Completed

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