Trial · NCT07895134
Psilocybin for Depression in Veterans
NCT07895134, Phase 2, Not yet recruiting, VA Office of Research and Development
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Psilocybin for Depression in Veterans. Trials, record NCT07895134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07895134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Psilocybin for Depression in Veterans
- NCT number
- NCT07895134
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, estimated
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Major Depression
- Interventions
- Psilocybin, modafinil, zolpidem, pimavanserin
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Depression Rating Scale-6 (HAMD-6) | Baseline to 30 and 90 days post-drug administration | A clinician-administered, 6-item version of the Hamilton Depression Rating Scale that assesses core depressive symptoms including depressed mood, guilt, work and activities, psychomotor retardation, psychic anxiety, and somatic symptoms. Scores range from 0-22, with higher scores indicating greater depression severity. Administered at Baseline, Day 1, Day 7, Day 30, and Day 90. |
| Secondary | Change in EEG-measured LTP-like visual plasticity from baseline to Day 7, assessed by P1-N1b visual evoked potential amplitude (micro volts) | Baseline to 7 days post-drug administration | LTP-like cortical plasticity will be assessed using an EEG-based visual stimulation paradigm. Visual evoked potential (VEPs) will be recorded before and after 10 minutes of repetitive checkerboard stimulation at 2 Hz. Within-session potentiation will be quantified as the change in P1-N1b peak-to-peak VEP amplitude (micro-volts) from pre- to post-stimulation. The outcome measure is the change in within-session potentiation from baseline to Day 7 following study drug administration, calculated as the D7 potentiation minus baseline potentiation.. |
| Secondary | Change in Multidimensional Psychological Flexibility Inventory (MPFI) | Baseline to 30 and 90 days post-drug administration | The Multidimensional Psychological Flexibility Inventory (MPFI) is a self-report questionnaire assessing psychological flexibility, the core therapeutic process in Acceptance and Commitment Therapy (ACT). The psychological flexibility score is calculated as the mean of six subscales: acceptance, present moment awareness, self as context, defusion, values, and committed action. Scores range from 1 to 6, with higher scores indicating greater psychological flexibility (better outcome). |
| Secondary | Change in Symptoms of Depression Questionnaire (SDQ) | Baseline to 30 and 90 days post-drug administration | The Symptoms of Depression Questionnaire (SDQ) is a 44-item self-report questionnaire assessing depressive symptoms across five domains: lassitude, mood, and cognitive functioning; anxiety, agitation, irritability, and anger; suicidal ideation; sleep disturbances; and appetite and weight changes. Each item is scored from 1 to 6, yielding a total score ranging from 44 to 264. Higher scores indicate greater depressive symptom severity (worse outcome). Administered at Baseline, Day 30, and Day 90. Endpoints include change from Baseline to Days 30 and 90 post-treatment. |
| Secondary | Change in Columbia-Suicide Severity Rating Scale - Suicidal Ideation Subscale (C-SSRS-SI) | Baseline to 30 and 90 days post-drug administration | The Columbia-Suicide Severity Rating Scale - Suicidal Ideation Subscale (C-SSRS-SI) is a structured assessment of suicidal ideation across five levels of increasing severity: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods, active suicidal ideation with intent, and active suicidal ideation with plan and intent. Scores range from 0 (no suicidal ideation) to 5 (active suicidal ideation with specific plan and intent), based on the highest severity level endorsed. Higher scores indicate more severe suicidal ideation (worse outcome). The score will be analyzed as a numerical measure of suicidal ideation severity. Trained study staff will administer the assessment at Baseline, Day 30, and Day 90. Endpoints include change from Baseline to Days 30 and 90 post-treatment. |
| Secondary | Change in WHO Disability Assessment 2.0 (WHODAS 2.0) | Baseline to 30 and 90 days post-drug administration | The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a self-report questionnaire assessing functional disability across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Standardized total scores range from 0 (no disability) to 100 (complete disability), with higher scores indicating greater functional disability (worse outcome). Administered at Baseline, Day 30, and Day 90. Endpoints include change from Baseline to Days 30 and 90 post-treatment. |
| Secondary | Change in EEG Theta Band Phase Synchrony | Baseline to 7 days post-drug administration. | Change in EEG theta-band (4-8 Hz) phase synchrony induced by repetitive visual stimulation, measured using intertrial coherence (ITC). ITC is a unitless measure ranging from 0 to 1, with higher values indicating greater consistency of neural oscillatory phase across trials. EEG assessments are performed at Baseline and Day 7, with changes in stimulation-induced ITC compared between visits. |
| Secondary | Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline to 30 days post-drug administration | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a centrally administered structured clinical interview assessing the 20 DSM-5 PTSD symptoms. The CAPS-5 provides both categorical PTSD diagnoses and continuous symptom severity scores. Each symptom is rated from 0 to 4, yielding a total severity score ranging from 0 to 80, with higher scores indicating greater PTSD symptom severity (worse outcome). Administered by trained, licensed clinical staff at Baseline and Day 30. The endpoint is change from Baseline to Day 30 post-drug administration. |
| Secondary | Change in EEG Theta Band Power | Baseline to 7 days post-drug administration | Change in EEG theta-band (4-8 Hz) power induced by repetitive visual stimulation, measured using a visual long-term potentiation (LTP)-like plasticity paradigm. EEG assessments are performed at Baseline and Day 7, with changes in stimulation-induced theta power compared between visits. |
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/NCT07895134
GET https://conductscience.org/api/trials/v1/NCT07895134/registered