Psilocybin to Treat Depression in Spinal Cord Injury

ConditionsSpinal Cord Injury Depression - Major Depressive Disorder Veteran

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age22+

SponsorJames J. Peters Veterans Affairs Medical Center

About this trial

The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).

The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses.

Participants will:

* Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent

Spinal cord injury for at least 1 year

Confirmed diagnosis of depression

At least 22 years of age at time of consent

Disqualifiers

Are not able to give adequate informed consent

Have used psilocybin or another psychedelic within 6 months

Have received Electroconvulsive Therapy (ECT) within 12 weeks

Have used ketamine within 12 weeks

Trial design

Design model

Sequential

Treatments tested in this trial

Psilocybin (Usona Institute)
Drug
Oral capsules

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: Psilocybin Low DoseExperimental treatment 1 intervention

Group B: Psilocybin Medium DoseExperimental treatment 1 intervention

Group C: Psilocybin High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of Participants with Treatment-Related Adverse Events as Assessed by the Adverse Events Log.

The Adverse Events Log will be captured by the research team at screening, before and after medication taper (if needed), weekly during the taper, at each of the three preparatory and three integration sessions, at 44 days post dose, and at all remote and in-person follow-up visits; 16 assessments in total.

Time frame

Screening through study completion, an average of 13 months.

Secondary outcomes

Clinician rated change from baseline (V1) in the Montgomery-Asberg Depression Rating Scale (MADRS) score at 44(+/-7) days post psilocybin dose (V9).

The MADRS is a ten-item diagnostic questionnaire that includes questions related to symptoms of (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. Each item yields a score of 0 to 6, with higher scores reflecting more severe depression. MADRS scores correspond to 0-6 (normal or no depression), 7-19 (mild depression), 20-30 (moderate depression), 31-39 (severe depression), and 40-60 (extremely severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-60.

Time frame

Baseline to 44 days post psilocybin.

Self reported change in depression severity score on the Beck Depression Inventory (BDI-II) from baseline (V1) to 44(+/-7) days post psilocybin (V9).

The BDI-II consists of four answer choices that are scored from 0 (no symptom) to 3 (severe symptom). Total BDI scores correspond to 0-9 (minimal depression), 10-18 (mild depression), 19-29 (moderate depression) and 30-63 (severe depression). Higher scores are indicative of higher levels of depression, range of scores 0-63.

Time frame

Baseline to 44 days post psilocybin.

Other outcomes

Change in self-reported levels of pain interference in daily life, overall mood, and sleep quality from baseline (V1) to 7 days post psilocybin (V7) using the International Spinal Cord Injury Pain Basic Data Set (iSCI-PBD).

The iSCI-PBD detects change in the number of painful condition types, the severity of pain, location of painful conditions, and pain interference in daily life, overall mood, and sleep quality. The outcome will include change in pain interference in daily life, overall mood, and sleep quality from baseline (V1) to 7 days post psilocybin (V7) using the iSCI-PBD with scores ranging from 0 (no interference) to 10 (extreme interference). Higher scores are indicative of higher levels of pain interference, range of scores 0-10.

Time frame

Baseline to 7 days post psilocybin.

Self-reported change in frequency and severity of spasms using the Penn Spasm Frequency Scale (PSFS) .

The PSFS is a self-report measure used to assess the perception (over a one-week time frame) of spasticity frequency on a 0 ("no spasm") to 4 ("spasms occurring more than 10 times per hour) scale, and severity on a 1 ("mild") to 3 ("severe") following SCI. The investigators will track change changes in spasms from baseline (V1) to 7 days post psilocybin (V7). Higher scores are indicative of higher levels of spasm frequency (score range 0-4) and spasm severity (score range 0-3).

Time frame

Baseline to 7 days post psilocybin.