A Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression

Rodrigo Machado-Vieira, MD, PhD, MSc34 enrolled

Overview

The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bipolar Depression

Interventions

Palmitoylethanolamide (PEA)DRUG

Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.

PlaceboDRUG

Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks

Treatment as Usual (TAU)DRUG

subjects will receive a mood stabilizer per usual care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D * currently in use of at least one FDA approved mood stabilizer with or without antidepressant * medically and neurologically healthy on the basis of medical history, physical examination Exclusion Criteria: * Cannabis misuse according to clinical judgement * unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects * active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder) * acute high suicidal risk * in a manic episode * current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination * pregnant or nursing women * unstable medical conditions * clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Depression as Assessed by the Hamilton Depression Rating Scale (HAM-D)

The Hamilton Depression Rating Scale measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity. The change in score will be reported. The change in score will be reported as the \[(Score at 6 weeks follow up) - (Score at Baseline)\] - A negative value indicates improvement of depression severity.

Time frame: Baseline, 6 weeks follow up

Secondary Outcomes

Number of Participants That Show a Remission of Depressive Symptoms as Assessed by the HAM-D Scale

Remission of depressive symptoms is defined by a HAM-D score of ≤7. The Hamilton Depression Rating Scale (HAM-D) measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity

Time frame: from baseline to end of study (6 week follow up)

Number of Participants That Show a Response as Assessed by the HAM-D Scale

Response rate is defined by ≥ 50 % reduction in HAM-D Score from baseline. The Hamilton Depression Rating Scale (HAM-D) measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity

Time frame: from baseline to end of study (6 week follow up)

Change in Depression as Assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)

The Montgomery Äsberg Depression Rating Scale measures severity in depression. The total score ranges from 0 to 60, a higher score indicating greater depression. The change in score will be reported. The change in score will be reported as the \[(Score at 6 weeks follow up) - (Score at Baseline)\] - A negative value indicates improvement of depression severity.

Time frame: Baseline, 6 weeks follow up

Time to Response - HAM-D (≥50% Reduction From Baseline)

Data from ClinicalTrials.gov

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