Effect of Behavioral Intervention on Cannabinoid Receptors in BAD (WHM_BAD)
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ClinicalTrials.gov Identifier: NCT04168697 |
Recruitment Status :
Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 20, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Affective Disorder, Currently in Remission Bipolar Disorder I Bipolar Disorder II | Behavioral: Wim Hof method | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patient group vs a control group |
Masking: | None (Open Label) |
Masking Description: | no masking |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Behavioral Intervention on the Cannabinoid Receptor System in Patients With Bipolar Affective Disorder |
Estimated Study Start Date : | February 1, 2020 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | February 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Controls
Control subjects undergoing an 8-week behavioral modification technique consisting of a combination of breathing exercises, cold exposure and meditation
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Behavioral: Wim Hof method
8-week behavioral modification intervention instructing the participants in a combination of breathing exercises, cold exposure and meditation |
Experimental: BAD
Patients with bipolar affective disorder (BAD) undergoing an 8-week behavioral modification technique consisting of a combination of breathing exercises, cold exposure and meditation
|
Behavioral: Wim Hof method
8-week behavioral modification intervention instructing the participants in a combination of breathing exercises, cold exposure and meditation |
- Cannabinoid PET imaging [ Time Frame: 12 weeks ]Changes in cannabinoid receptor density measured using F18-FMPEP-d2 PET/CT imaging pre and post behavioral intervention

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BAD type I or II, in clinical remission of acute mood episode at least 3 months prior to study
- Having experienced an acute affective episode in the past 3 years
- Having suffered at least two lifetime depressive episodes
- Monotherapy or combination with a mood stabilizer (lithium, valproate, carbamazepine or lamotrigine) at optimal doses, quetiapine monotherapy or in combination with the aforementioned stabilizers, any oral atypical antipsychotic in combination with an antidepressant
- Hamilton Depression Rating Scale (HDRS) score (>8 and <19) and Young Mania Rating Scale (YMRS) score <10
- Being able to understand and agree with requirements of study protocol
Exclusion Criteria:
- (i) Any acute mood episode in the 12 weeks before the start of the trial
- Any current DSM-IV diagnosis different from BAD (including substance or alcohol use disorder at the time of study entry, except if it is under complete remission. Not applicable to nicotine or caffeine)
- Risk of suicide or self/hetero aggressiveness
- Pregnancy
- Severe and unstable medical disease
- Mental retardation.

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): NCT04168697
Contact: Otto Muzik | 3139932616 | otto@pet.wayne.edu | |
Contact: Vaibhav Diwadkar | 3135770164 | vaibhav.diwadkar@wayne.edu |
United States, Michigan | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 |
Responsible Party: | Otto Muzik, Professor of Pediatrics, Wayne State University |
ClinicalTrials.gov Identifier: | NCT04168697 |
Other Study ID Numbers: |
19061167 |
First Posted: | November 19, 2019 Key Record Dates |
Last Update Posted: | November 20, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | At this to we plan to share only summary data that will be published in peer-reviewed journals. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Genetic Diseases, X-Linked Disease Bipolar Disorder Mood Disorders |
Pathologic Processes Bipolar and Related Disorders Mental Disorders Genetic Diseases, Inborn |