- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168697
Effect of Behavioral Intervention on Cannabinoid Receptors in BAD (WHM_BAD)
November 18, 2019 updated by: Otto Muzik, Wayne State University
The Effect of Behavioral Intervention on the Cannabinoid Receptor System in Patients With Bipolar Affective Disorder
The objective of this study is to determine whether the practice of a non-drug related intervention technique (behavioral modification technique consisting of a combination of breathing exercises, cold exposure and meditation) has an effect on long-term cannabinoid receptor function in a control group as well as in a group of patients suffering from bipolar affective disorder (BAD).
Specifically, the objective of this study is to test whether the applied behavioral modification technique is able to alter cannabinoid receptor density in brain areas that modulate mood and motivational drive (such as vmPFC, PAG, VTA, amygdala and OFC).
The investigators believe that these studies will form the impetus for a better understanding and deployment of non-drug related treatment methods in patients with various depressive symptoms.
In particular, it appears that the proposed behavioral modification technique might be a powerful, currently under-appreciated, method to positively modulate the brain's own cannabinoid system.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Bipolar affective disorder (BAD) is often poorly controlled by prescribed drugs.
Clinical observations suggest that the endocannabinoid system is dysfunctional in BAD and fails to control the level of cortical excitation and inhibition in the brain.
Thus, excessively high endocannabinoid tone (mania) or excessively low endocannabinoid tone (depression) may manifest itself in BAD patients.
Interestingly, cannabis use is common in patients with this disorder and anecdotal reports suggest that some patients take it to alleviate symptoms of both mania and depression.
The investigators have recently studied brain activations during a cold stress paradigm in a 57 year old Dutch national (Wim Hof), the so-called "Iceman", who has the ability to withstand frequent prolonged periods of extreme cold exposure using a self-developed technique that includes a combination of breathing exercises, cold exposure and meditation (referred to as the WH technique).
The WH technique allows the "Iceman" to regulate his own autonomic nervous system in the presence of severe cold and to perform remarkable acts of survival under extreme thermal conditions.
Moreover, it has been shown that the WH technique can be successfully taught to novice users.
Preliminary studies performed by the investigators have examined CNS mechanisms associated with the practice of the WH technique and the obtained findings unequivocally demonstrated activation of autonomic brainstem areas that are implicated in stress-induced analgesia as well as cognitive cortical areas that are associated with self-reflection (such as the anterior insula).
In particular, a strong activation of the periaqueductal gray (PAG) was determined, which is implicated in the release of endogenous opiates/cannabinoids that mediate decreased sensitivity to cold exposure and (via connections to higher-order cortical areas) promote a feeling of euphoria and well-being.
This finding suggests that the WH technique might allow practitioners to assert increased level of control over key components of the affective system and as a result might be a viable, non-drug related approach for patients with pathological mood swings.
The investigators believe that this method might be particularly effective in patients suffering from BAD, as the practice of the WH technique can be implemented during both remission and at the onset of highly motivational manic episodes, which will then help to limit the effects of negative mood swings during depressive (and manic) episodes.
The investigators will study the effects of the WH technique on cannabinoid receptor density using the cannabinoid PET tracer (F18-FMPEP-d2) by determining regional changes in cannabinoid receptor density in various brain regions prior and post behavioral intervention.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
8-week behavioral modification intervention instructing the participants in a combination of breathing exercises, cold exposure and meditation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19061167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
At this to we plan to share only summary data that will be published in peer-reviewed journals.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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