Psilocybin and Depression (Psilo101)
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|ClinicalTrials.gov Identifier: NCT03380442|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Severe Depression||Drug: Psilocybin Drug: Ketamine (Ketalar)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In a randomized, double-blind placebo-controlled design, 20 of the participants will receive ketamine, and 20 will receive psilocybin. 20 of the participants will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified. The no-treatment group will only attend the initial clinical interviews, and their depressive symptoms will be assessed remotely.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Since the psilocybin is ingested orally in capsule form, whereas ketamine is administered intranasally, the participants will either receive a placebo capsule containing microcrystalline cellulose (if they belong to the group receiving ketamine), or intranasally administered saline solution (with added bitter flavoring which will mimic the taste of ketamine that is often detectable even when administered intranasally).|
|Primary Purpose:||Basic Science|
|Official Title:||Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Psilocybin group
This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions.
Psilocybin ingested orally
Active Comparator: Ketamine group
This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions.
Drug: Ketamine (Ketalar)
Ketamine administered intranasally
No Intervention: No-treatment group
This group will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified
- The 16-Item Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 6 months ]The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of ≤5 on the QIDS.
- The Montgomery and Asberg Depression Rating Scale [ Time Frame: 3 months ]The Montgomery and Asberg Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
- Hamilton Depression Rating Scale [ Time Frame: 3 months ]The Hamilton Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380442
|Contact: Mona E Moisala, PhD||504480044 ext +firstname.lastname@example.org|