Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia
Overview
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.
Full Title of Study: “Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Double
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.
Interventions
- Drug: reboxetine adjuvant therapy
Clinical Trial Outcome Measures
Primary Measures
- sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test
Secondary Measures
- esrs, progesterom, sexual functioning, covy, cgi, cgi improved
Participating in This Clinical Trial
Inclusion Criteria
- schizophrenia all types – 18> Exclusion Criteria:
- uti – >65 – non organic state – no depression treatment
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Abarbanel Mental Health Center
- Overall Official(s)
- stanislav baranchik, md, Principal Investigator, abarbanel mhc
- Overall Contact(s)
- stanislav baranchik, md, 972-3-5552625
References
Schutz G, Berk M. Reboxetine add on therapy to haloperidol in the treatment of schizophrenia: a preliminary double-blind randomized placebo-controlled study. Int Clin Psychopharmacol. 2001 Sep;16(5):275-8. doi: 10.1097/00004850-200109000-00004.
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