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Depressive Disorder, MajorPhase 2NCT03559192

A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

A Phase 2 study testing JNJ-67953964 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 53 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
JNJ-67953964
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
53 sitesin 6 countries
Study dates
16 Jul 2018to 6 May 2020
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)
  • Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
  • Participants must have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Major Depressive Disorder (MDD)
  • The current episode should be less than 18 months
  • Participants should be currently treated with an SSRI or SNRI at an adequate dose and for at least 6 weeks but no more than 12 months
  • Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 25 at screening
  • A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose

Who cannot join

  • History of documented gastric disease (including documented peptic ulcer disease, gastritis, upper gastrointestinal [GI] bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints
  • 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 for example in cardiovascular disease prevention is allowed)
  • Has a history of alcohol use disorder within the past year
  • Has failed (no more than 25 percent [%] response on Antidepressant Treatment History Questionnaire [ATRQ]) three or more antidepressant treatments including the current Selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks)
  • Has signs or symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamus pituitary adrenal (HPA) axis
  • Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or has participated in any interventional clinical studies on MDD in the previous 1 year or is currently enrolled in an interventional study
Show all 21Show fewer
  • Has one or more of the following diagnoses:
  • A primary DSM (5th edition) diagnosis of generalized anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD). Participants with comorbid GAD, social anxiety disorder (SAD), or panic disorder for whom MDD is considered the primary diagnosis are not excluded
  • A current diagnosis or diagnosis in the past 1 year of psychotic disorder, MDD with psychosis, anorexia nervosa or bulimia nervosa, chronic fatigue syndrome, bipolar disorder (BD), mental retardation, antisocial or borderline personality disorder, autism spectrum disorder
  • 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 Colombia suicide severity rating scale (C-SSRS), or a history of suicidal behavior within the past 1 year
  • Ongoing psychological treatments (example, Cognitive Behavior Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy, etcetera [etc.]), initiated within 1 month prior to the screening phase. A participant who has been receiving ongoing psychological treatment for a period of greater than 1 month from the screening visit is eligible, if the investigator deems the psychological treatment to be of stable duration and frequency
  • Participant has a history of substance use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before screening. Mild cases can be reviewed on a case by case basis. Participants who have completed a treatment for (alcohol) addiction more than 1 year prior to first dose administration, may be included if the risk of relapse is considered minimal, total duration of alcohol use disorder was less than a year, and no significant abnormalities are shown in clinical laboratory or other pre-dose safety assessments
  • Participant has used:
  • Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening
  • St. John's wort, ephedra, ginkgo, ginseng, or kava within 2 weeks before screening
  • Antipsychotic drugs (D2-antagonists) within 2 weeks before screening. However, Seroquel (quetiapine) in a dose less than or equals to (<=)100 milligram (mg) is allowed when used in a stable dose for at least 8 weeks prior to screening. Quetiapine treatment should be continued unchanged during the study
  • Opioids within 2 weeks before screening
  • Psychostimulants such as methylphenidate or dextroamphetamine within 2 weeks before screening
  • Psychotropics with antidepressant effects such as atomoxetine or thyroid supplementation, in addition to their SSRI or SNRI treatment within 2 weeks before screening
  • Participant is unable to stop the following medication from the baseline visit (Visit 2) and throughout the study (tapering during screening period allowed): Any hypnotics including but not limited to: i. Benzodiazepines when used only as needed (PRN) are not allowed ii. Sedating antihistamines, including chronic use of diphenhydramine iii. Continuous use of zolpidem, zoplicon, eszopiclone and ramelteon. Note: Nonbenzodiazepines sleep aids (including: zolpidem, zaleplon, and eszopliclone) are allowed on an as needed (PRN) basis during the study but NOT within 24 hours before being in the clinic and not more than 2 nights in a row iv. S-adenosyl methionine (SAMe) v. Melatonin, agomelatine
  • Has received any prior treatment with electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device or treatment with ketamine or esketamine for MDD

Trial locations and contacts

53 sites in 6 countries.

53 sites in 6 countries

United States28 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chicago Research Center

    Chicago, Illinois, 60634

  • Ohio State University

    Columbus, Ohio, 43210

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Behavioral Research Specialists LLC

    Glendale, California, 91206

  • Clinical Trials of America

    Hickory, North Carolina, 28601

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Clinical NeuroScience Solutions Inc

    Memphis, Tennessee, 38119

  • Innova Clinical Trials

    Miami, Florida, 33133

  • Galiz Research

    Miami Springs, Florida, 33166

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma, 73118

  • NRC Research Institute

    Orange, California, 92868

  • APG Research LLC

    Orlando, Florida, 32803

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • Psychiatric Medicine Associates LLC

    Skokie, Illinois, 60076

  • Richmond Behavioural Associates

    Staten Island, New York, 10312

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Meridien Research

    Tampa, Florida, 33634

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

  • Advanced Clinical Research

    West Jordan, Utah, 84088

Other trials in United States

Russia11 sites

  • Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

    Moscow, 107076

  • Orenburg Regional Clinical Psychiatric Hospital #1

    Orenburg

  • Medical and Rehabilitation Research Center Phoenix

    Rostov-on-Don, 344002

  • St-Petersburg Bekhterev Psychoneurological Research Institute

    Saint Petersburg, 192019

  • City Psychiatric hospital 7 named after I.P.Pavlov

    Saint Petersburg, 199034

  • Psychoneurological dispensary 1

    Saint Petersburg, 199178

  • SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

    Saratov, 410028

  • Saratov Regional Psychiatric hospital named after St. Sofia

    Saratov, 410060

  • Engels psychiatric hospital

    Saratov Region, 413124

  • Research Institute of Mental Health

    Tomsk, 634014

  • Sverdlovsk Regional Clinical Psychiatric Hospital

    Yekaterinburg

Other trials in Russia

Ukraine6 sites

  • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

    Hlevakha, 8630

  • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

    Kharkiv, 61068

  • CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

    Kherson, 73488

  • Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

    Kyiv, 2660

  • Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

    Nove, 25491

  • CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

    Smila, 20708

Other trials in Ukraine

United Kingdom5 sites

  • MAC Clinical Research

    Barnsley, S75 3DL

  • MAC Clinical Research

    Blackpool, FY2 0JH

  • MAC Clinical Research

    Liverpool, L34 1BH

  • Hammersmith Medicines Research Ltd

    London, NW10 7EW

  • MAC Clinical Research

    Manchester, M139NQ

Other trials in United Kingdom

Germany2 sites

  • Emovis GmbH

    Berlin, 10629

  • Somni Bene GmbH

    Schwerin, 19053

Other trials in Germany

Moldova1 site

  • ARENSIA

    Chisinau, MD2025

Other trials in Moldova

About this study

Official title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.

Being tested
JNJ-67953964, Placebo
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • JNJ-67953964Drug

    JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.

  • PlaceboDrug

    Matching placebo will be administered as 2 capsules orally once daily.

Study groups in NCT03559192
Study groupRoleWhat they receive
Lead-in Period: PlaceboPlacebo comparatorParticipants will receive matching placebo for the entire duration of the lead-in period.
Receives: Drug: Placebo
Treatment Period: JNJ-67953964 or PlaceboExperimentalParticipants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks.
Receives: Drug: JNJ-67953964; Drug: Placebo
Withdrawal Period: PlaceboPlacebo comparatorParticipants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Treatment Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Treatment Week 6 in Participants Who Were Non-Responders During Placebo Lead-in Period

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

Secondary outcomes (18)

  1. Change From Treatment Baseline in MADRS Total Score at Treatment Week 6

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period

    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. TEAEs were AEs with onset during the treatment period that has worsened since baseline.

    Measured: Up to Week 6

  3. Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population)

    The SHAPS is a self-reported 14-item, instrument, developed for the assessment of hedonic capacity. Participants scored whether they experienced pleasure in performing a list of activities or experiences. Participants rated the answers as 1-4 where 1 indicates "Definitely agree", 2 indicates "Agree", 3 indicates "Disagree" and 4 indicates "Definitely disagree". The participant's item responses were summed to provide a total score ranging from 14 to 56. A higher total SHAPS score indicated higher levels of current anhedonia. Negative change from baseline indicated improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  4. Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT)

    The SHAPS is a self-reported 14-item, instrument, developed for the assessment of hedonic capacity. Participants scored whether they experienced pleasure in performing a list of activities or experiences. Participants rated the answers as 1-4 where 1 indicates "Definitely agree", 2 indicates "Agree", 3 indicates "Disagree" and 4 indicates "Definitely disagree". The participant's item responses were summed to provide a total score ranging from 14 to 56. A higher total SHAPS score indicated higher levels of current anhedonia. Negative change from baseline indicated improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  5. Change From Treatment Baseline in Clinical Global Impression - Severity (CGI-S) Score at Treatment Week 6 (eITT Population)

    CGI-S provides an overall clinician-determined summary measure of severity of participant's illness that considers all available information, including knowledge of participant's history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Participant is assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill participants. Negative change in score indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  6. Change From Treatment Baseline in CGI-S Score at Treatment Week 6 (fITT Population)

    CGI-S provides an overall clinician-determined summary measure of severity of participants illness that considers all available information, including knowledge of participant's history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Participant is assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill participants. Negative change in score indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  7. Change From Treatment Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Treatment Week 6 (eITT Population)

    The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item was rated by the participant according to a 5-point Likert scale. Participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). Before summing the items to create a total score, item 11 ("how often did you have a poor appetite") and item 12 ("how often did you over eat") were combined into a single score by selecting the highest severity on either item. The total score was then created by summing the responses on the 15 items. The total score ranged from 0 to 60. The SMDDS uses a 7-day recall period and verbal rating scales. Higher score indicates more severe depressive symptomatology. Negative change from baseline indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  8. Change From Treatment Baseline in SMDDS Total Score at Treatment Week 6 (fITT Population)

    The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item was rated by the participant according to a 5-point Likert scale. Participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). Before summing the items to create a total score, item 11 ("how often did you have a poor appetite") and item 12 ("how often did you over eat") were combined into a single score by selecting the highest severity on either item. The total score was then created by summing the responses on the 15 items. The total score ranged from 0 to 60. The SMDDS uses a 7-day recall period and verbal rating scales. Higher score indicates more severe depressive symptomatology. Negative change from baseline indicates improvement.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  9. Number of Participants With Self-Assessment of Treatment Experience (SATE) Questionnaire at Treatment Week 6 (eITT Population)

    SATE questionnaire is a 3-item self-reported scale designed to provide additional information regarding participant's subjective experience while taking treatment. This was internal Janssen questionnaire and questions were asked to participant weekly by the Q1.6-app. For rating overall depression: participant selected one option out of Improved, not changed or got worse; for depression improvement: participant selected one option out of slightly improved, much improved or very much improved; and for depression worsen: participant selected slightly worse, much worse or very much worse.

    Measured: Treatment Week 6

  10. Number of Participants With SATE Questionnaire at Treatment Week 6 (fITT Population)

    SATE questionnaire is a 3-item self-reported scale designed to provide additional information regarding participant's subjective experience while taking treatment. This was internal Janssen questionnaire and questions were asked to participant weekly by the Q1.6-app. For rating overall depression: participant selected one option out of Improved, not changed or got worse; for depression improvement: participant selected one option out of slightly improved, much improved or very much improved; and for depression worsen: participant selected slightly worse, much worse or very much worse.

    Measured: Treatment Week 6

  11. Change From Treatment Baseline in Hamilton Anxiety Scale 6 (HAM-A6) Total Score at Treatment Week 6 (eITT Population)

    HAM-A scale assesses severity of different anxiety-related symptoms with a score range of 0 to 52. Higher score indicated severity in anxiety symptoms. Each of the 14 items is rated by clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). HAM-A6 is a uni-dimensional, 6-item subscale derived from HAM-A. HAM-A6 comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behaviour observed at the interview, as well as one somatic item, muscular tension. HAM-A6 subscale score ranges from 0 to 24, with higher scores indicating greater severity of core symptoms.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  12. Change From Treatment Baseline in HAM-A6 Total Score at Treatment Week 6 (fITT)

    HAM-A scale assesses severity of different anxiety-related symptoms with a score range of 0 to 52. Higher score indicated severity in anxiety symptoms. Each of the 14 items is rated by clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). HAM-A6 is a uni-dimensional, 6-item subscale derived from HAM-A. HAM-A6 comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behaviour observed at the interview, as well as one somatic item, muscular tension. HAM-A6 subscale score ranges from 0 to 24, with higher scores indicating greater severity of core symptoms.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  13. Change From Treatment Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Score at Treatment Week 6 (eITT Population)

    SIGH-A is a 14-item scale to measure severity of different anxiety-related symptoms in participants. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). The SIGH-A total score is calculated by summing the 14 item scores, and ranges from 0 to 56 where higher score indicates worsening.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  14. Change From Treatment Baseline in SIGH-A Score at Treatment Week 6 (fITT Population)

    SIGH-A is a 14-item scale to measure severity of different anxiety-related symptoms in participants. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). The SIGH-A total score is calculated by summing the 14 item scores, and ranges from 0 to 56 where higher score indicates worsening.

    Measured: Treatment Baseline up to Week 6 of DB-treatment period

  15. Maximum Observed Plasma Concentration (Cmax) of JNJ-67953964

    Cmax was defined as maximum observed plasma concentration of JNJ-67953964.

    Measured: Week 1: Day 29, Week 3: Day 43, Week 6 (Day 64)

  16. Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC[0-24h]) of JNJ-67953964

    AUC(0-24h) was defined as the area under the plasma concentration-time curve from time of administration to 24 hours.

    Measured: 0 to 24 hours Post dose on Week 1: Day 29, Week 3: Day 43, Week 6: Day 64

  17. Area Under Plasma Concentration-Time Curve at Steady State (AUCss) of JNJ-67953964

    AUCss was defined as the area under plasma concentration-time curve at Steady State (AUCss) of JNJ-67953964.

    Measured: Week 1: Day 29, Week 3: Day 43, Week 6: Day 64

  18. Predose (Trough) Plasma Concentration (C0h) of JNJ-67953964

    C0h was defined as predose plasma Concentration of JNJ-67953964.

    Measured: Predose on Week 1: Day 29, Week 3: Day 43, Week 6: Day 64

Timeline

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

  1. First posted18 Jun 2018
  2. Study start16 Jul 2018
  3. Primary completion6 May 2020
  4. Study completion6 May 2020

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559192
Sponsor's protocol ID
CR108487
Other IDs
67953964MDD2001, 2019-000695-41, 2019
Status last verified
Apr 2025
First submitted
6 Jun 2018
Last updated
29 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-67953964 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 53 sites in 6 countries.

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 7 inclusion and 21 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Russia, Ukraine, United Kingdom, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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 26 Jun 2023). 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?

Change From Treatment Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Treatment Week 6 in Participants Who Were Non-Responders During Placebo Lead-in Period (time frame: Treatment Baseline up to Week 6 of DB-treatment period). 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 NCT03559192.

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 29 Apr 2025.

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