Psilocybin for Major depressive disorder, recurrent episode

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Canadian Rapid Treatment Centre of Excellence (CRTCE), Mississauga, Canada
Major depressive disorder, recurrent episode+3 More
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether psilocybin is safe and well tolerated.

See full description

Eligible Conditions

  • Major depressive disorder, recurrent episode

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Major depressive disorder, recurrent episode

Study Objectives

This trial is evaluating whether Psilocybin will improve 3 primary outcomes and 24 secondary outcomes in patients with Major depressive disorder, recurrent episode. Measurement will happen over the course of Up to 2 weeks.

Up to 2 weeks
Peripheral inflammatory and metabolic biomarkers
Up to 20 weeks
Brief Psychiatric Rating Scale (BPRS)
Clinician-Administered Dissociative States Scale (CADSS), 23-item
Clinician-Administered Dissociative States Scale (CADSS), 6-item
Mystical Experiences Questionnaire (MEQ)
Young Mania Rating Scale (YMRS)
Up to 24 weeks
Clinical Global Impressions Scale (CGI)
Columbia Suicide Severity Rating Scale (CSSRS)
Digit Symbol Substitution Test (DSST)
EuroQol-5D 5-Level (EQ-5D-5L)
Feasibility of the study based on adverse events
Feasibility of the study based on participant retention
Feasibility of the study based on suicidal ideation and behaviour scores
Generalized Anxiety Disorder-7 (GAD-7)
McIntyre and Rosenblat Rapid Response Scale (MARRRS)
Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate
Montgomery-Åsberg Depression Rating Scale (MADRS) response rate
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Patient Health Questionnaire 9-item (PHQ-9)
Perceived Deficits Questionnaire - Depression - 5-Item (PDQ-5-D)
Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16)
Sheehan Disability Scale (SDS)
Snaith-Hamilton Pleasure Scale (SHAPS)
Trail Making Test A (TMT-A)
Trail Making Test B (TMT-B)
World Health Organization-5 Well-Being Index (WHO-5)
World Productivity and Impairment Questionnaire (WPAI)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Major depressive disorder, recurrent episode

Side Effects for

Session #1 Through 1-week Post-session #1 Follow-up
Headache
29%
Heart rate event
8%
Physical discomfort
4%
Visual distortion
4%
Mild controllable muscle motion
4%
Blood pressure event
4%
Chest tightness
0%
Altered body sensation
0%
Vivid dreams
0%
Tenseness/soreness
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03181529) in the Session #1 Through 1-week Post-session #1 Follow-up ARM group. Side effects include: Headache with 29%, Heart rate event with 8%, Physical discomfort with 4%, Visual distortion with 4%, Mild controllable muscle motion with 4%.

Trial Design

2 Treatment Groups

Delayed treatment
1 of 2
Immediate treatment
1 of 2
Experimental Treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Psilocybin is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Delayed treatment
Drug
Participants will commence psilocybin treatment two weeks after study enrollment.
Immediate treatment
Drug
Participants will commence psilocybin treatment immediately upon study enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 weeks for reporting.

Closest Location

Canadian Rapid Treatment Centre of Excellence (CRTCE) - Mississauga, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Major depressive disorder, recurrent episode or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Over the age of 18 years and under the age of 65;
Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider;
Experiencing a major depressive episode (MDE) without psychotic features as defined and operationalized in the DSM-5, where the duration of the current episode is at least 3 months;
Have failed to respond to an adequate dose and duration of at least two guideline-concordant pharmacological treatments for the current MDE, as determined by the Massachusetts General Hospital-Antidepressant Treatment History Questionnaire;
Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Current or past history of bipolar I disorder, schizophrenia, psychotic disorder, delusional disorder, paranoid personality disorder, or schizoaffective disorder, as assessed by a structured clinical interview (MINI) and International Personality Disorder Examination (IPDE);
First degree history of schizophrenia or any psychotic disorders, including bipolar disorder with psychotic features;
Currently experiencing symptoms of hypomania or mania as measured by the Young Mania Rating Scale (YMRS) total score > 12;
History of a hypomanic or manic episode in the past 3 months;
History of substance use and/or alcohol use disorder, of moderate severity or greater, in the past 3 months;

Patient Q&A Section

What does psilocybin usually treat?

"While some patients were remarkably improved, the effect of psilocybin for the treatment of PD was still unsatisfactory. These data suggest that the psilocybin therapy is still a promising new therapeutic method for PD, but further studies are needed to clarify the mechanism of action with psilocybin-induced symptomatology." - Anonymous Online Contributor

Unverified Answer

Can depressive disorder, treatment-resistant be cured?

"Although the mechanism underlying the improvement of depression after medical treatment is not fully elucidated, antidepressant medications are an effective and effective method in treating depression even if the patient is not completely cured." - Anonymous Online Contributor

Unverified Answer

What is depressive disorder, treatment-resistant?

"Treating physicians need to be vigilant toward a depressive disorder diagnosis to implement effective treatment for depression and provide adequate psychological support for their patients. In addition, the impact of depression on the quality of lives of the patients with depression and their willingness for effective treatment of depression should always be considered." - Anonymous Online Contributor

Unverified Answer

What are common treatments for depressive disorder, treatment-resistant?

"A large proportion of subjects were not treated or only given medication and CBT as first line. Effective treatment and better compliance to treatment would be more effective for people with depressive disorder, especially when with treatment-resistant symptomatology." - Anonymous Online Contributor

Unverified Answer

What are the signs of depressive disorder, treatment-resistant?

"Signs of the depressive disorder include persistent sadness and hopelessness that interfere with the daily life. There is a strong connection between depression and exhaustion. Depressive disorder occurs in patients who had been diagnosed with a mental illness (mainly in depressed patients), who had been given different treatment strategies, including the antidepressant therapy." - Anonymous Online Contributor

Unverified Answer

What causes depressive disorder, treatment-resistant?

"Although the exact mechanism underlying treatment-resistant depression is not clear, there is evidence that this may be part of the mechanisms underlying other chronic disorders. Attention to non-adherence to treatment as well as maintenance of a regular routine may reduce the risk that treatment-resistant depression will not respond as expected to treatment." - Anonymous Online Contributor

Unverified Answer

How many people get depressive disorder, treatment-resistant a year in the United States?

"About 700,000 to 1.3 million people suffer from a first episode of depression that worsens without treatment a year. This can be prevented with early initiation of treatment using agents that are effective in preventing recurrence." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of psilocybin?

"Psilocybin has a wide variety of effects with low overall side-effect rate. These effects span over most physiological systems, including the central nervous system, but also include gastrointestinal symptoms such as aldate and nausea. Most side effect events are thought to be secondary rather than direct effects of the drug." - Anonymous Online Contributor

Unverified Answer

Does depressive disorder, treatment-resistant run in families?

"While the majority of DMR in this sample of BD and MDD were found to have a positive family history, the prevalence of DMR in these groups was not statistically different, suggesting that DMR is possibly not a specific PD subtype. However, for a subgroup of BD patients with DMR, a positive family history was statistically associated with more severe current disability and a more frequent recurrence of depressive episodes throughout their illness course." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating depressive disorder, treatment-resistant?

"There has been a shortage of efficacious, stable antidepressant medications in the last 7 years. This shortage has been cited as one reason for a high number of depressed patients not presenting for treatment. There is a need for clinical study investigating the safety and efficacy of newer antidepressants in the treatment of patients with treatment-resistant depression." - Anonymous Online Contributor

Unverified Answer

What is the latest research for depressive disorder, treatment-resistant?

"Evidence-based treatments for depression have improved over time, but depression remains a major psychiatric health issue, with a very high number of patients not improving after receiving the recommended treatments." - Anonymous Online Contributor

Unverified Answer

How does psilocybin work?

"Results from a recent trial examining the effects of psilocybin are encouraging, but a more thorough and carefully designed clinical trial would greatly benefit the field. ClinicalTrials.gov identifier: NCT00223038." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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