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
Baszucki Brain Research Fund
The University of Texas Health Science Center, Houston
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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage 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 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 |
| Percentage 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 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 |
| Number of participants that show early improvement as defined by >20% improvement in HAM-D depression score | From baseline to week 2 visit | 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 |
| Change in depression as assessed by the Montgomery Äsberg Depression Rating Scale (MADRS) | Baseline, 6 weeks follow up | This is a 10 item questionnaire and each is scored from 0 -6 for a maximum score of 60, higher score indicating worse outcome |
Countries
United States
Outcome results
None listed