Effect of SSRIs on Response to Psilocybin Therapy (NCT05594667) | Clinical Trial Compass
WithdrawnPhase 2
Effect of SSRIs on Response to Psilocybin Therapy
Stopped: Funding
Canada0Started 2023-01-01
Plain-language summary
This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups:
* Group 1: ≤ 1 year
* Group 2: 1 to ≤ 5 years
* Group 3: 5 to ≤ 10 years
* Group 4: \> 10 years
Who can participate
Age range19 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female, 19 to 65 years of age
✓. Fluent in English
✓. Currently receiving treatment with an SSRI (consistent dose for at least 6 weeks), with no changes anticipated throughout the duration of the study
✓. QIDS-SR-16 score ≥6
✓. Clinically diagnosed Major Depressive Disorder by a psychiatrist prior to screening 5a. Diagnosis defined as meeting the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria (American Psychiatric Association, 2013) for MDD
✓. MADRS score 7-34 inclusive (mild-moderate)
✓. Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
✓. Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.
Exclusion criteria
✕. Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history
✕. Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.
What they're measuring
1
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)