Reboxetine Treatment in Depressed Children and Adolescents an 8-Week, Open Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by Geha Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Geha Mental Health Center
ClinicalTrials.gov Identifier:
NCT00426946
First received: January 24, 2007
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Reboxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Reboxetine Treatment in Depressed Children and Adolescents an 8-Week, Open Study

Resource links provided by NLM:


Further study details as provided by Geha Mental Health Center:

Secondary Outcome Measures:
  • Children’s Depression Inventory CDI (Kovacs, 1985)
  • Children’s Depression Rating Scale-Revised (CDRS-R)

Estimated Enrollment: 60
Study Start Date: January 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426946

Contacts
Contact: Paz Toren, MD 972522248287 ptoren@post.tau.ac.il

Locations
Israel
Tel Aviv Community Mental Helath Center Recruiting
Tel Aviv, Israel
Contact: Paz Toren, MD    972522248287    ptoren@post.tau.ac.il   
Sponsors and Collaborators
Geha Mental Health Center
Investigators
Principal Investigator: Paz Toren TACMHC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426946     History of Changes
Other Study ID Numbers: TACMHC1
Study First Received: January 24, 2007
Last Updated: January 24, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Geha Mental Health Center:
Depression Children Reboxetine
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.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Reboxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014