A clinical study to explore the efficacy of JNJ-67953964 in the treatment of depressio
- Conditions
- Major Depressive DisorderMedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-000695-41-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. Subjects must be men or women, 18 to 64 years of age, inclusive.
Note: Subjects should be at least 18 years of age or older as per the legal age of consent in the jurisdiction in which the study is taking place.
2. Have a Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI = weight/height2).
3. Subjects must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening and baseline (Visit 2) For clinical laboratory tests only screening results will be considered. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase. In 12-lead ECG, QTcF should be = 450 msec for males or = 470 msec for females and PR interval < 220 msec at screening. A retest of an abnormal ECG value will be allowed once in the screening phase. Blood pressure will be the average of 2 measurements.
The subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
4. Population specific:
- Subjects must have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis (confirmed by an independent central rater through review of the MINI interview obtained by the site at screening). The current episode should be less than 18 months.
- Subjects must be currently treated with an SSRI/SNRI antidepressant approved in this protocol (see Section 6.5) at an adequate dose, as defined by the ATRQ, and for at least 6 continuous weeks but not more than 12 months.
- Have a MADRS total score =25 at screening. If 2 weeks or more elapse between the MADRS rating at screening and Visit 2, the local rater will complete the MADRS again by a telephone interview up to 4 days before Visit 2. At this telephone interview, MADRS total score should again be =25 and should not demonstrate a clinically significant change (i.e., an improvement of >20%).
- In a common population of subject suffering from MDD, about 90% have a SHAPS total score >20. The SHAPS total score will initially not be an inclusion criterion. However, after 50 subjects have been randomized, the subjects’ properties will be reviewed. If less than 50% of non-responding subjects have a SHAPS total score >20, then for the remaining subjects the following inclusion criterion will be added:
- Have a SHAPS total score >20 at screening and baseline (Visit 2)
5. 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/gel/film/cream/suppository for the duration of the study plus 3 months after receiving the last dose of study drug, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an addi
1. Has current signs/symptoms of, liver or renal insufficiency, hypothyroidism or hyperthyroidism (a normal thyroid-stimulating function is required at screening; subjects who are on stable treatment with thyroid supplementation with normal thyroid-stimulating hormone [TSH] may participate but subjects with thyroid supplementation for antidepressant purposes are not allowed in the study*), significant cardiac disease (including current or past history of atrial fibrillation/flutter), vascular, pulmonary, endocrine, neurologic (including epilepsy), hematologic, inflammatory (e.g., rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease) or metabolic disturbances. Diabetes mellitus (DM) may be allowed when the subject is stable (HbA1c less than 7.5% or 58 mmol/mol).
*Subjects with known hypothyroidism who have been on stable treatment for at least 3 months prior to screening are required to have TSH and free thyroxine (FT4) obtained. Any subject with an elevated TSH should also have FT4 measured. In any case where the TSH value is out of range, but FT4 is normal, the findings should be discussed directly with the medical monitor before the subject is enrolled. If the FT4 value is out of range, the subject is not eligible.
2. History of documented gastric disease (including documented peptic ulcer disease, gastritis, upper GI bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints.
3. Chronic use of a proton pump inhibitors (PPIs). History of incidental use of PPIs is allowed but should have been stopped at least 4 weeks before screening. A history of chronic nonsteroidal anti-inflammatory drug (NSAID) or aspirin use. (Low dose aspirin e.g. in cardiovascular disease prevention is allowed).
4. Has a history of alcohol use disorder within the past year.
5. Criterion modified by Amendment INT-1 and INT-2.
5.2. Has failed (no more than 25% response on ATRQ) three or more antidepressant treatments including the current SSRI/SNRI during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks).
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