An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants with Major Depressive Disorder with Anxious Distress
- Conditions
- Major Depressive DisorderAnxietyMedDRA version: 20.0Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000024349Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-002007-29-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1. Subject must be a man or woman between 18 and 64 years of age,
inclusive.
2. Subjects must have a primary DSM-5 diagnosis of MDD with Anxious Distress. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD with Anxious Distress to be the primary diagnosis (confirmed by an independent central rater through review of the MINI interview obtained by the site at screening). Subjects must have been treated with an SSRI/SNRI antidepressant approved in this protocol at an adequate dose, as defined by the ATRQ, and for at least 6 continuous weeks, validated by an independent central rater contracted by the sponsor.
3. A HDRS17 total score = 18 at screening, assessed by a site rater and
validated through review by an independent central rater contracted by the sponsor; and on Day 1 by site rater.
4. A HDRS17 anxiety/somatization factor score =7at screening, assessed by a site rater and validated through review by an independent central rater contracted by the sponsor; and on Day 1 by site rater
5. Before randomization, a woman must be either:
• Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/L); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
• Of childbearing potential and practicing a highly effective method of
birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies (i.e. one that results in a less than 1% per year failure rate when used
consistently and correctly). This may include:
o Established and ongoing use of oral hormonal methods of
contraception in combination with barrier methods.
o Established and ongoing use of patch, injected or implanted hormonal methods of contraception.
o Placement of an IUD or IUS.
Accepted barrier methods as indicated above include:
- condom with spermicidal foam/gel/film/cream/suppository
- occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository
Note that a barrier method on its own is not sufficient
o Male partner sterilization (the vasectomized partner should be the sole partner for that subject).
o True abstinence (when this is in line with the preferred and usual
lifestyle of the subject).
Women must agree to continue using these methods of contraception
throughout the study and for at least 3 months after receiving the last
dose of study medication.
Note: If a woman of childbearing potential who is not heterosexually
active becomes active after the start of the study, she must begin a
highly effective method of birth control, as described above.
• All women must have a negative pregnancy test at screening and a
negative urine pregnancy test on study day 1.
• All women must agree not to donate eggs (ova, oocytes) for the
purposes of assisted reproduction during the study and for at least 3
months after receiving the last dose of study drug.
6. Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam
Any potential subject who meets any of the following criteria will be
excluded from participating in the study unless otherwise specified:
1. Has any other current major psychiatric condition, including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, posttraumatic stress disorder, borderline personality disorder, eating
disorder (e.g., bulimia, anorexia nervosa), or schizophrenia.
The MINI will be conducted by the primary investigator/sub-investigator (either a psychiatrist or Ph.D. psychologist) at Screening to confirm MDD as the primary diagnosis. In addition, an independent rater will confirm that the current depressive episode is valid as well as verifying any comorbid psychiatric conditions validated in
the MINI. As noted, subjects with a diagnosis of comorbid GAD, Social
Anxiety Disorder, or Panic Disorder may be included.
2. Has a length of current major depressive episode (MDE) >6 months.
3. Has initiated psychotherapy specific for MDD (such as cognitive
behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to screening. Subjects receiving psychotherapy can continue receiving psychotherapy provided this therapy has been stable in frequency for the last 6
months and will remain unchanged throughout the study treatment.
4. Has more than 1 failed treatment with antidepressants of adequate
dose and duration in the current major depressive episode, prior to and not including the inadequate response to the current SSRI/SNRI
antidepressant
5. Has a history of resistance to medication treatment of major
depressive episodes (=3 lifetime treatment failures with approved
antidepressants at adequate doses and duration).
6. 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 CSSRS at screening or Day 1. Subjects with a prior suicide attempt, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method