Trial · NCT03559192
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With SATE Questionnaire at Treatment Week 6 (fITT Population) | Treatment Week 6 | (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. Here 'n' (number analyzed) refers to all participants evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Treatment Baseline in Hamilton Anxiety Scale 6 (HAM-A6) Total 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, 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 HAM-A6 Total Score at Treatment Week 6 (fITT) | 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 Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) 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 SIGH-A 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 | Maximum Observed Plasma Concentration (Cmax) of JNJ-67953964 | Week 1: Day 29, Week 3: Day 43, Week 6 (Day 64) | eITT population 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. Here 'n' (number analyzed) refers to all participants evaluable for specified time point categories. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC[0-24h]) of JNJ-67953964 | 0 to 24 hours Post dose on Week 1: Day 29, Week 3: Day 43, Week 6: Day 64 | eITT population 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. Here 'n' (number analyzed) refers to all participants evaluable for specified time point categories. | nanograms*hour per milliliter (ng*h/mL) | MEAN |
| SECONDARY | Area Under Plasma Concentration-Time Curve at Steady State (AUCss) of JNJ-67953964 | Week 1: Day 29, Week 3: Day 43, Week 6: Day 64 | eITT population 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. Here 'n' (number analyzed) refers to all participants evaluable for specified time point categories. | ng*h/mL | MEAN |
| SECONDARY | Predose (Trough) Plasma Concentration (C0h) of JNJ-67953964 | Predose on Week 1: Day 29, Week 3: Day 43, Week 6: Day 64 | eITT population 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. Here 'n' (number analyzed) refers to all participants evaluable for specified time point categories. | nanograms per milliliter (ng/ml) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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