NCT00557427

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

November 13, 2007

Last Update Submit

June 23, 2011

Conditions

Depression

Keywords

mild to moderate depression according to the DSM-IV scale

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (4)

  • 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

    8 weeks

  • Time to clinical response

    8 weeks

Study Arms (2)

A

EXPERIMENTAL

hypericum 250mg tablets twice daily for 8 weeks

Drug: hypericum

B

ACTIVE COMPARATOR

fluoxetine 20mg - 40mg daily for 8 weeks

Drug: fluoxetine

Interventions

hypericumDRUG

250mg tablets twice daily for 8 weeks

Also known as: Remotiv
A
fluoxetineDRUG

20mg - 40mg daily for 8 weeks

B

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

Related Publications (2)

  • 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.

    PMID: 12874492RESULT

  • 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.

    PMID: 15910213RESULT

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

IL(1)