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Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Abarbanel Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Abarbanel Mental Health Center
ClinicalTrials.gov Identifier:
NCT00409201
First received: December 7, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.


Condition Intervention Phase
Schizophrenia
 Drug: reboxetine adjuvant therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Abarbanel Mental Health Center:

Primary Outcome Measures:
  • sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test

Secondary Outcome Measures:
  • esrs, progesterom, sexual functioning, covy, cgi, cgi improved

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: November 2006
Detailed Description:

all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg * 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. * 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • schizophrenia all types
  • 18>

Exclusion Criteria:

  • uti
  • >65
  • non organic state
  • no depression treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409201

Contacts
Contact: stanislav baranchik, md 972-3-5552625

Locations
Israel
Abarbanel Medical Mental Health Center Recruiting
Bat Yam, Israel, 59100
Contact: stanislav baranchik, md     972-3-5552625        
Contact: alex aviv, md     972-3-552703     alexaviv@gmail.com    
Principal Investigator: stanislav baranchik, md            
Abarbanel Medical Mental Health Center Recruiting
Bat Yam, Israel, 59100
Principal Investigator: stanislav baranchik, md            
Sponsors and Collaborators
Abarbanel Mental Health Center
Investigators
Principal Investigator: stanislav baranchik, md abarbanel mhc
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00409201     History of Changes
Other Study ID Numbers: 284
Study First Received: December 7, 2006
Last Updated: December 7, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Abarbanel Mental Health Center:
schizophrenia
reboxetine
cognitive
behavior

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Adjuvants, Immunologic
Reboxetine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antidepressive Agents
 Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013