Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00409201
• Other study ID #: 284
• Status: Recruiting
• Phase: Phase 1
• First received: December 7, 2006
• Last updated: December 7, 2006
• Start date: March 2006
• Est. completion date: November 2006

Study information

• Verified date: March 2006
• Source: Abarbanel Mental Health Center
• Contact: stanislav baranchik, md
• Phone: 972-3-5552625
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• schizophrenia all types

• 18>

Exclusion Criteria:

• uti

• >65

• non organic state

• no depression treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• reboxetine adjuvant therapy

Locations

Country	Name	City	State
Israel	Abarbanel Medical Mental Health Center	Bat Yam
Israel	Abarbanel Medical Mental Health Center	Bat Yam

Sponsors (1)

Lead Sponsor	Collaborator
Abarbanel Mental Health Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test
Secondary	esrs, progesterom, sexual functioning, covy, cgi, cgi improved