Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| REM-1/MDA |
Not provided
Not provided
Not provided
Lack of enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests, urinalysis and ECG.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | hypericum 250mg tablets twice daily for 8 weeks |
|
| B | Active Comparator | fluoxetine 20mg - 40mg daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypericum | Drug | 250mg tablets twice daily for 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a decrease of CDRS-R score > 30 points from baseline | 8 weeks | |
| Final mean CDRS-R score | 8 weeks | |
| Change in CDRS-R score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Apter, MD | Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12874492 | Result | Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14. doi: 10.1097/01.CHI.0000046900.27264.2A. | |
| 15910213 | Result | Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301. doi: 10.1089/cap.2005.15.293. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 14, 2020 | |
| Reset | Jan 7, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 14, 2020 | Jan 7, 2021 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fluoxetine | Drug | 20mg - 40mg daily for 8 weeks |
|
| 8 weeks |
| Time to clinical response | 8 weeks |