Effect of Behavioral Intervention on Cannabinoid Receptors in BAD

Status unconfirmed · Not applicable

Conditions studied: Bipolar Affective Disorder, Currently in Remission, Bipolar Disorder I, Bipolar Disorder II

In brief

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.

Key facts

Study ID

NCT04168697

Run by

Wayne State University

People needed

20

Starts

2020-02-01

Expected to finish

2021-02-01

Last updated by the study team

2019-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Children's Hospital of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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