NCT00426946

Brief Summary

The aim of the present study is to prospectively assess the anti-depressant effectiveness of reboxetine in children and adolescents, as compared with fluoxetine, in a randomized controlled open-label trial.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
Last Updated

January 25, 2007

Status Verified

September 1, 2004

First QC Date

January 24, 2007

Last Update Submit

January 24, 2007

Conditions

Depression

Keywords

Depression Children ReboxetineA diagnosis of major depressive disorder or a dysthimic disorder according to DSM-IV-TR.Drug naïve or without chronic medication for at least one month.Only children who agree to participate and whose parents will sign and informed consent form will be included.

Outcome Measures

Secondary Outcomes (2)

  • Children's Depression Inventory CDI (Kovacs, 1985)

  • Children's Depression Rating Scale-Revised (CDRS-R)

Interventions

ReboxetineDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A diagnosis of major depressive disorder or a dysthimic disorder according to DSM-IV-TR.
  • Drug naïve or without chronic medication for at least one month.
  • Only children who agree to participate and whose parents will sign and informed consent form will be included.

You may not qualify if:

  • A diagnosis of a psychotic disorder or bipolar disorder.
  • Mental retardation.
  • Alcohol or drug abuse
  • Chronic medical condition
  • Girls (\> 12 years) will not be included in the study if a possibility of pregnancy during the study exists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Community Mental Helath Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Reboxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paz Toren

    TACMHC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paz Toren, MD

CONTACT

972522248287ptoren@post.tau.ac.il

Study Design

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

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 25, 2007

Study Start

January 1, 2005

Last Updated

January 25, 2007

Record last verified: 2004-09

Locations

IL(1)