Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

• Sponsor: Abarbanel Mental Health Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00409201
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Duration (Months): 8
• Patients Per Site: 15
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: reboxetine adjuvant therapy	Phase 1

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Phase 1 Study of Reboxetine Adjuvant Therapy and Cognitive and Behavioral Measures
• Study Start Date: Mar 1, 2006
• Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test []

Secondary Outcome Measures

1. esrs, progesterom, sexual functioning, covy, cgi, cgi improved []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• schizophrenia all types

• 18>

Exclusion Criteria:

• uti

• 65

• non organic state

• no depression treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abarbanel Medical Mental Health Center	Bat Yam		Israel	59100
2	Abarbanel Medical Mental Health Center	Bat Yam		Israel	59100

Sponsors and Collaborators

• Abarbanel Mental Health Center

Investigators

• Principal Investigator: stanislav baranchik, md, abarbanel mhc

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00409201
• Other Study ID Numbers: 284
• First Posted: Dec 8, 2006
• Last Update Posted: Dec 8, 2006
• Last Verified: Mar 1, 2006

• Keywords provided by , ,: schizophrenia; reboxetine; cognitive; behavior
• Additional relevant MeSH terms: Schizophrenia; Reboxetine

Study Results

No Results Posted as of Dec 8, 2006