Trial · NCT04116528
Opiate Suicide Study in Patients With Major Depression
NCT04116528, Phase 3, Completed, Stanford University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Opiate Suicide Study in Patients With Major Depression. Trials, record NCT04116528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04116528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Opiate Suicide Study in Patients With Major Depression
- NCT number
- NCT04116528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Major Depressive Disorder
- Interventions
- Buprenorphine, Placebo
- First posted
- 2019-10-04
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Scale for Suicidal Ideation (SSI) Total Scores Will be Analyzed as the Primary Outcome Measure Using Mixed Effects Models, | Day 1 and 31 | Analyses included a modified intention-to-treat population, defined as all randomized participants who received one week of treatment and completed the week 1 assessment of buprenorphine or placebo. A linear mixed-effects model tested the primary hypothesis of efficacy, measured by change in SSI total scores. The model included random effects for patient and fixed effects for treatment group, time as a continuous variable (days of study: 1, 3, 10, 17, 24, 31), and the time-by-treatment group interaction, along with an unstructured covariance matrix. The SSI has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation. |
| Secondary | MADRS Change Score | Day 1 and 31 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. |
| Secondary | HAM-D Change Score | Day 1 and 31 | The Hamilton Depression Scale (HAM-D) is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression. |
| Other | The Investigators Will Assess Opioid Activity of Ketamine as Well as Buprenorphine | Day 3-31 | peripherally by exploring opioid activity in subjects treated in the ketamine infusion and the sublingual buprenorphine vs. placebo phases by measuring serum metabolites of both ketamine and buprenorphine. The metabolites are measured in ng/mL with a reference interval of 1-10. Any presence of the drug will result in a number within the interval. If none detected, a not established level will be the result. |
| Other | Serum Prolactin Level | Day 1 and 3-31. | Levels of the hormone prolactin may be increased by opioids and ketamine in serum. |
| Other | Pupillometry | change from Day 3-31 | Moreover, we will apply pupillometry to estimate opioid activity. Levels of drug and opioid activity at specific time points will be correlated with response at that time point. In addition, regression analyses will be used to assess the relative contribution of opioid activity in blood, drug blood level, and pupil measure to improvement in suicidal behavior as well as mood, pain, and insomnia. This aim is exploratory. |
Source ClinicalTrials.gov
Outcomes0
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/NCT04116528
GET https://conductscience.org/api/trials/v1/NCT04116528/registered