Trial · NCT03559192
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
NCT03559192, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2023-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression. Trials, record NCT03559192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03559192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
- NCT number
- NCT03559192
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Depressive Disorder, Major
- Interventions
- JNJ-67953964, Placebo
- First posted
- 2018-06-18
- Last updated
- 2025-04-29
- Other registries' IDs
- eudract:2019-000695-41
- Results first posted
- 2023-06-26
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Treatment Baseline up to Week 6 of DB-treatment 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. |
| Secondary | Change From Treatment Baseline in MADRS Total Score at Treatment Week 6 | Treatment Baseline up to Week 6 of DB-treatment 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period | Up to Week 6 | 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. |
| Secondary | Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Change From Treatment Baseline in Clinical Global Impression - Severity (CGI-S) Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Change From Treatment Baseline in CGI-S Score at Treatment Week 6 (fITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Change From Treatment Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Change From Treatment Baseline in SMDDS Total Score at Treatment Week 6 (fITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | 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. |
| Secondary | Number of Participants With Self-Assessment of Treatment Experience (SATE) Questionnaire at Treatment Week 6 (eITT Population) | Treatment Week 6 | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Treatment Baseline up to Week 6 of DB-treatment period | The enriched intent-to-treat (eITT) analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Treatment Baseline in MADRS Total Score at Treatment Week 6 | Treatment Baseline up to Week 6 of DB-treatment period | The full intent-to-treat (fITT) analysis set included all enrolled participants who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-treatment baseline assessment of MADRS during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period | Up to Week 6 | The full safety analysis set included all enrolled participants who received at least 1 dose of study medication in the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of participants analyzed) includes the number of participants evaluable for this outcome measure. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT) | Treatment Baseline up to Week 6 of DB-treatment period | The fITT analysis set included all enrolled participants who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-treatment baseline assessment of MADRS during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Treatment Baseline in Clinical Global Impression - Severity (CGI-S) Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, had at least 1 post-baseline MADRS assessment during treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Change From Treatment Baseline in CGI-S Score at Treatment Week 6 (fITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | fITT analysis set included all enrolled participants who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-treatment baseline assessment of MADRS during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Change From Treatment Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Treatment Week 6 (eITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Change From Treatment Baseline in SMDDS Total Score at Treatment Week 6 (fITT Population) | Treatment Baseline up to Week 6 of DB-treatment period | fITT analysis set included all enrolled participants who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-treatment baseline assessment of MADRS during the treatment period. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Self-Assessment of Treatment Experience (SATE) Questionnaire at Treatment Week 6 (eITT Population) | Treatment Week 6 | The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'n' (number analyzed) refers to all participants evaluable for specified categories. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Double-blind Treatment + Withdrawal Period: Placebo | -8.0 | Standard Error 0.92 | scores on a scale | |
| 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 | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | -10.1 | Standard Error 0.93 | scores on a scale | |
| Change From Treatment Baseline in MADRS Total Score at Treatment Week 6 | Double-blind Treatment + Withdrawal Period: Placebo | -6.5 | Standard Error 0.78 | scores on a scale | |
| Change From Treatment Baseline in MADRS Total Score at Treatment Week 6 | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | -9.6 | Standard Error 0.79 | scores on a scale | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period | Double-blind Treatment + Withdrawal Period: Placebo | 30 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 40 | Participants | ||
| Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population) | Double-blind Treatment + Withdrawal Period: Placebo | -3.7 | Standard Error 0.64 | scores on a scale | |
| Change From Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 (eITT Population) | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | -4.4 | Standard Error 0.64 | scores on a scale | |
| Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT) | Double-blind Treatment + Withdrawal Period: Placebo | -3.7 | Standard Error 0.55 | scores on a scale | |
| Change From Treatment Baseline in SHAPS Total Score at Treatment Week 6 (fITT) | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | -4.5 | Standard Error 0.55 | scores on a scale |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-in Period (3 Weeks) | STARTED | Lead in Period: Placebo | 181 | |
| Lead-in Period (3 Weeks) | STARTED | Double-blind Treatment + Withdrawal Period: Placebo | 0 | |
| Lead-in Period (3 Weeks) | STARTED | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 0 | |
| Lead-in Period (3 Weeks) | COMPLETED | Lead in Period: Placebo | 169 | |
| Lead-in Period (3 Weeks) | COMPLETED | Double-blind Treatment + Withdrawal Period: Placebo | 0 | |
| Lead-in Period (3 Weeks) | COMPLETED | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 0 | |
| Lead-in Period (3 Weeks) | NOT COMPLETED | Lead in Period: Placebo | 12 | |
| Lead-in Period (3 Weeks) | NOT COMPLETED | Double-blind Treatment + Withdrawal Period: Placebo | 0 | |
| Lead-in Period (3 Weeks) | NOT COMPLETED | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 0 | |
| DB Treatment(6 Wks) + Withdrawal(2 Wks) | STARTED | Lead in Period: Placebo | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Lead in Period: Placebo | 6 | 169 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Treatment + Withdrawal Period: Placebo | 2 | 84 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 7 | 85 | |
| other | Nasopharyngitis | Infections and infestations | Lead in Period: Placebo | 6 | 169 | |
| other | Nasopharyngitis | Infections and infestations | Double-blind Treatment + Withdrawal Period: Placebo | 3 | 84 | |
| other | Nasopharyngitis | Infections and infestations | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 6 | 85 | |
| other | Headache | Nervous system disorders | Lead in Period: Placebo | 11 | 169 | |
| other | Headache | Nervous system disorders | Double-blind Treatment + Withdrawal Period: Placebo | 7 | 84 | |
| other | Headache | Nervous system disorders | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 10 | 85 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Lead in Period: Placebo | 1 | 169 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lead in Period: Placebo | 0 | 169 |
| Total, all-cause mortality | Double-blind Treatment + Withdrawal Period: Placebo | 0 | 84 |
| Total, all-cause mortality | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 0 | 85 |
| Total, other adverse events | Lead in Period: Placebo | 21 | 169 |
| Total, other adverse events | Double-blind Treatment + Withdrawal Period: Placebo | 10 | 84 |
| Total, other adverse events | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 23 | 85 |
| Total, serious adverse events | Lead in Period: Placebo | 0 | 169 |
| Total, serious adverse events | Double-blind Treatment + Withdrawal Period: Placebo | 1 | 84 |
| Total, serious adverse events | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | 0 | 85 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) vs Double-blind Treatment + Withdrawal Period: Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03559192/results?page=2