Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

December 7, 2006 updated by: Abarbanel Mental Health Center

Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Bat Yam, Israel, 59100
        • Recruiting
        • Abarbanel Medical Mental Health Center
        • Principal Investigator:
          • stanislav baranchik, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schizophrenia all types
  • 18>

Exclusion Criteria:

  • uti
  • >65
  • non organic state
  • no depression treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test

Secondary Outcome Measures

Outcome Measure
esrs, progesterom, sexual functioning, covy, cgi, cgi improved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abarbanel Mental Health Center

Investigators

  • Principal Investigator: stanislav baranchik, md, Abarbanel MHC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2006

Last Update Submitted That Met QC Criteria

December 7, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 284 (NHLBI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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