Trial · NCT01582815
A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms
NCT01582815, Phase 2, Completed, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms. Trials, record NCT01582815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01582815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms
- NCT number
- NCT01582815
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Major Depressive Disorder
- Interventions
- JNJ-40411813, Placebo
- First posted
- 2012-04-23
- Last updated
- 2015-06-16
- Other registries' IDs
- eudract:2011-006121-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score | Baseline, Week 4 | The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms. |
| Secondary | The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score | Baseline, Week 4 | The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression. |
| Secondary | The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score | Baseline, Week 4 | The (HAM-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. |
| Secondary | The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale | Baseline, Week 4 | The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Secondary | The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score | Baseline, Week 4 | The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression. |
| Secondary | The change from baseline to endpoint in the HAM-D6 score | Baseline, Week 4 | The HAM-D6 is a 6-item subscale derived from the Hamilton Depression Rating Scale (HDRS17). The rating scale measures the severity of depressive symptomatology. Higher scores represent more severe depressive symptoms. |
| Secondary | The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score | Baseline, Week 6 | The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. Scores range from 0 to 84 with higher scores representing greater severity of depressive symptoms. |
| Secondary | The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale | Baseline, Week 4 | The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. The anxiety subscale includes five anxiety symptoms: anxious mood, somatic complaints, sympathetic arousal, panic, and gastrointestinal symptoms. The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms. |
| Secondary | The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ) | Baseline, Week 4 | The WLQ is a 25-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment ("work limitations"), with a recall period of the previous 2 weeks. It comprises four dimensions of limitations: handling time, physical, mental-interpersonal, and output demands. Patients respond to each item with options ranging from "Almost all of the time" to "none of the time", or "Does not apply to my job". The global score ranges from 0 to 100 with lower score indicating low level of work limitations. |
| Secondary | The change from baseline to endpoint on the Perceived Stress Scale (PSS) | Baseline, Week 4 | The PSS is a 10-item, self-reported unidimensional instrument developed to measure perceived stress in response to situations in a person's life. Prevalence of an item within the last month is measured on a 5 point scale, ranging from "never" to "very often". Higher scores reflect higher levels of perceived stress. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT01582815
GET https://conductscience.org/api/trials/v1/NCT01582815/registered