Effect of Behavioral Intervention on Cannabinoid Receptors in BAD

NCT04168697 | Unknown DMC

• 1 other identifier: 19061167
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Affective Disorder, Currently in Remission; Bipolar Disorder I; Bipolar Disorder II

Outcome Measures

Primary Outcomes (1)

• Cannabinoid PET imaging

  Changes in cannabinoid receptor density measured using F18-FMPEP-d2 PET/CT imaging pre and post behavioral intervention

  12 weeks

Study Arms (2)

Controls

EXPERIMENTAL

Control subjects undergoing an 8-week behavioral modification technique consisting of a combination of breathing exercises, cold exposure and meditation

Behavioral: Wim Hof method

BAD

EXPERIMENTAL

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

Interventions

Wim Hof method BEHAVIORAL

8-week behavioral modification intervention instructing the participants in a combination of breathing exercises, cold exposure and meditation

BAD; Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Otto Muzik

CONTACT

3139932616; otto@pet.wayne.edu

Vaibhav Diwadkar

CONTACT

3135770164; vaibhav.diwadkar@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Patient group vs a control group

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: February 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)