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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Primary Purpose

Depression

Status

Terminated

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

hypericum

fluoxetine

About this trial

This is an interventional treatment trial for Depression focused on measuring mild to moderate depression according to the DSM-IV scale

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent
Adolescents aged 12 to 18 years
Patients meeting the criteria for mild to moderate depression according to the DSM-IV scale
Physical and laboratory examination at baseline compatible with study criteria
ECG at baseline compatible with study criteria
Score of at least 40 on the Children's Depression Rating Scale - Revised (CDRS-R) at baseline

Exclusion Criteria:

Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder
Patients with epilepsy
Patients with a history of alcohol or substance abuse in the past year
Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study.
Patients who have previously failed to respond to SSRI's or SRNI's
Patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine)
Patients with a contraindication to taking either Remotiv or fluoxetine or taking medication contraindicated when taking Remotiv or fluoxetine

Sites / Locations

Schneider Children's Medical Center of Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

hypericum 250mg tablets twice daily for 8 weeks

fluoxetine 20mg - 40mg daily for 8 weeks

Outcomes

Primary Outcome Measures

Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit

Secondary Outcome Measures

Percentage of patients with a decrease of CDRS-R score > 30 points from baseline

Final mean CDRS-R score

Change in CDRS-R score

Time to clinical response

Full Information

NCT ID

NCT00557427

First Posted

November 13, 2007

Last Updated

June 23, 2011

Sponsor

Rafa Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00557427

Brief Title

Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Official Title

Open-labeled Randomized Comparative Study of the Efficacy and Tolerability of Two Times Daily 250mg Hypericum Versus Once Daily 20 - 40 mg Fluoxetine in Adolescent Patients With Mild to Moderate Depression

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

January 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rafa Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

mild to moderate depression according to the DSM-IV scale

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

hypericum 250mg tablets twice daily for 8 weeks

Arm Title

Arm Type

Active Comparator

Arm Description

fluoxetine 20mg - 40mg daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

hypericum

Other Intervention Name(s)

Remotiv

Intervention Description

250mg tablets twice daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

fluoxetine

Intervention Description

20mg - 40mg daily for 8 weeks

Primary Outcome Measure Information:

Title

Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Percentage of patients with a decrease of CDRS-R score > 30 points from baseline

Time Frame

8 weeks

Title

Final mean CDRS-R score

Time Frame

8 weeks

Title

Change in CDRS-R score

Time Frame

8 weeks

Title

Time to clinical response

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Adolescents aged 12 to 18 years Patients meeting the criteria for mild to moderate depression according to the DSM-IV scale Physical and laboratory examination at baseline compatible with study criteria ECG at baseline compatible with study criteria Score of at least 40 on the Children's Depression Rating Scale - Revised (CDRS-R) at baseline Exclusion Criteria: Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder Patients with epilepsy Patients with a history of alcohol or substance abuse in the past year Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study. Patients who have previously failed to respond to SSRI's or SRNI's Patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine) Patients with a contraindication to taking either Remotiv or fluoxetine or taking medication contraindicated when taking Remotiv or fluoxetine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Apter, MD

Organizational Affiliation

Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schneider Children's Medical Center of Israel

City

Petach Tikva

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

12874492

Citation

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.

Results Reference

result

PubMed Identifier

15910213

Citation

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.

Results Reference

result

Learn more about this trial

Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

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