Bipolar Depression
Conditions
Keywords
cytokine levels
Brief summary
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
Interventions
Participants will receive PEA at a dose of 600mg twice daily for 6 weeks.
DRUGPlacebo
Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
DRUGTreatment as Usual (TAU)
subjects will receive a mood stabilizer per usual care
Sponsors
Rodrigo Machado-Vieira, MD, PhD, MSc
Baszucki Brain Research Fund
Milken Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression as Assessed by the Hamilton Depression Rating Scale (HAM-D) | Baseline, 6 weeks follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Show a Remission of Depressive Symptoms as Assessed by the HAM-D Scale | from baseline to end of study (6 week follow up) | 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 |
| Number of Participants That Show a Response as Assessed by the HAM-D Scale | from baseline to end of study (6 week follow up) | 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 |
| Change in Depression as Assessed by the Montgomery Äsberg Depression Rating Scale (MADRS) | Baseline, 6 weeks follow up | 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 to Response - HAM-D (≥50% Reduction From Baseline) | Baseline To Week 6 | Time to first study visit at which a participant achieved ≥50% reduction from baseline HAM-D total score. 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRodrigo Machado-Vieira, M.D, Ph.D., M.Sc
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Risk Score | 1 score on a scale STANDARD_DEVIATION 0 |
| Hamilton Depression Rating Scale Score | 21 score on a scale STANDARD_DEVIATION 1 |
| Montgomery Äsberg Depression Rating Scale Score | 28 score on a scale STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 3 / 18 | 3 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
None listed