Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/12/2019 |
| Start Date: | June 30, 2018 |
| End Date: | April 2023 |
| Contact: | Uma Dieffenbach, BA |
| Email: | uma.dieffenbach@yale.edu |
| Phone: | (203) 932-5711 |
The primary goal of this pilot study is to investigate whether psilocybin alters
neuroplasticity in people with major depressive disorder. The primary hypothesis is that
psilocybin will result in neuroplastic changes that parallel improvement in symptoms of
depression.
neuroplasticity in people with major depressive disorder. The primary hypothesis is that
psilocybin will result in neuroplastic changes that parallel improvement in symptoms of
depression.
In this placebo-controlled, blinded study, individuals with depression will participate in 2
experimental sessions approximately 4 weeks apart during which they will receive two of the
following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium
dose psilocybin (0.3 mg/kg).
experimental sessions approximately 4 weeks apart during which they will receive two of the
following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium
dose psilocybin (0.3 mg/kg).
Inclusion Criteria:
- Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and
currently experiencing a Major Depressive Episode (MDE)
- Failed to achieve a satisfactory clinical response to at least one adequate
antidepressant trial during the current depressive episode
- Currently engaged in treatment with a mental health clinician
Exclusion Criteria:
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- Axis I psychotic disorder in first degree relative
- Currently taking a conventional antidepressant medication
- Unstable medical or neurological conditions
- Significant cognitive disorders
- History of intolerance to drugs known to significantly alter perception e.g.,
psilocybin, LSD, salvinorin A, mescaline, etc.
- Pregnant, breastfeeding, lack of adequate birth control
- Urine toxicology positive to drugs of abuse on experimental test days
We found this trial at
1
site
West Haven, Connecticut 06516
Principal Investigator: Deepak Cyril D'Souza, MD
Phone: 203-932-5711
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