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| Name | Class |
|---|---|
| Baszucki Brain Research Fund | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA plus Treatment as Usual (TAU) | Experimental |
| |
| Placebo plus Treatment as Usual (TAU) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoylethanolamide (PEA) | Drug | Participants will receive PEA at a dose of 600mg twice daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline to end of study (6 week follow up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Machado-Vieira, M.D, Ph.D., M.Sc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
| D013812 | Therapeutics |
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| Placebo | Drug | Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks |
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| Treatment as Usual (TAU) | Drug | subjects will receive a mood stabilizer per usual care |
|
| 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 | 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 | 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 | Baseline, 6 weeks follow up |