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

The University of Texas Health Science Center, Houston34 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)

This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome

Time frame: Baseline, 6 weeks follow up

Secondary Outcomes

Percentage of participants that show a remission of depressive symptoms as assessed by the HAM-D scale.

Remission of depressive symptoms are defined by a score of ≤7 on the HAM-D. This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome

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

Percentage of participants that show a response as assessed by the HAM-D scale

Response rate is defined by ≥ 50 % reduction in depression score(HAM-D). This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome

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

Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score

This is a 13 item questionnaire and each is scored from 0-2 for a maximum score of 26 , a higher score indicating worse outcome

Time frame: From baseline to week 2 visit

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

This is a 10 item questionnaire and each is scored from 0 -6 for a maximum score of 60, higher score indicating worse outcome

Time frame: Baseline, 6 weeks follow up

Data from ClinicalTrials.gov

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