- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409201
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
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 Contact
- Name: stanislav baranchik, md
- Phone Number: 972-3-5552625
Study Locations
-
-
-
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
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.
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
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Adrenergic Uptake Inhibitors
- Reboxetine
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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