Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
ConditionMajor Depression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development
About this trial
The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veteran of the U.S. military who is English-speaking
Signed informed consent and HIPAA
Adults </= 75 years of age
Meets DSM-5 criteria for current major depressive episode (MDE)
Disqualifiers
Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders
First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder
Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)
Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugPsilocybin comparator dose
Psilocybin
DrugPsilocybin Intervention Dose
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Montgomery-Asberg Rating Scale (MADRS)
10-item clinician-administered rating scale for depression. Scored 0 to 60; higher score indicates more severe symptomatology.
Time frame
2 weeksSecondary outcomes
1
Swiss Psychedelic Side Effects Inventory Overall Score
A clinician guided self-report form that has a list of effects pertaining to psychedelics; has the option to add other side effects (or expected effects) as desired and includes an open text field to provide additional details that are not captured in the inventory list. In addition to rating severity of the side effects, the SPSI captures impact, causality, timing and duration, and has a global rating on tolerability. Scoring: Calculate total scores for the number of side effects, severity, and impact by adding the relevant columns. Calculate total scores for the number of side effects, severity, and impact by adding the relevant columns. The overall score is calculated by subtracting total severity from total impact. The overall score represents the burden of side effects for that person within the specified timeframe.
Time frame
one dayOther outcomes
1
Clinician-Administered PTSD Scale for DSM-5 - Revised
A 30-item interview used to rate the past-month PTSD severity in those participants diagnosed with PTSD by CAPS-5-R at baseline. Higher score (0 to 200) indicates higher PTSD severity.
Time frame
one month2
Hamilton Depression Rating Scale
A validated rater-administered measure of depression severity. The 17-item version yields a score of 0 to 50; higher score indicates more severe depression.
Time frame
two weeks3
Patient Health Questionnaire 9
A 9-item self-report measure designed to characterize severity of depression; has excellent psychometrics, total score range 0 to 27, higher = more severe.
Time frame
two weeks4
PTSD Checklist for DSM-5
A 20-item self-report of PTSD symptoms; score 0-80; higher=more severe. Only collected in those with PTSD diagnosis at baseline.
Time frame
one monthSponsors and contacts
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Source ClinicalTrials.gov