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

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

This study is currently recruiting participants.
Verified by Geha Mental Health Center, September 2004

Sponsored by:	Geha Mental Health Center
Information provided by:	Geha Mental Health Center
ClinicalTrials.gov Identifier:	NCT00426946

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 IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

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

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

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

Study ID Numbers:	TACMHC1
First Received:	January 24, 2007
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00426946
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.

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Reboxetine

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on September 23, 2008