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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2004 by Geha Mental Health Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426946
First Posted: January 25, 2007
Last Update Posted: January 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Geha Mental Health Center
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Reboxetine Treatment in Depressed Children and Adolescents an 8-Week, Open Study

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00426946     History of Changes
Other Study ID Numbers: TACMHC1
First Submitted: January 24, 2007
First Posted: January 25, 2007
Last Update Posted: January 25, 2007
Last Verified: September 2004

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
Behavioral Symptoms
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs