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Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

NCT ID: NCT00409201

Last Updated: 2006-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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schizophrenia reboxetine cognitive behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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reboxetine adjuvant therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* schizophrenia all types
* 18\>

Exclusion Criteria

* uti
* \>65
* non organic state
* no depression treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abarbanel Mental Health Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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stanislav baranchik, md

Role: PRINCIPAL_INVESTIGATOR

abarbanel mhc

Locations

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Abarbanel Medical Mental Health Center

Bat Yam, , Israel

Site Status RECRUITING

Abarbanel Medical Mental Health Center

Bat Yam, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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stanislav baranchik, md

Role: CONTACT

Phone: 972-3-5552625

Facility Contacts

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stanislav baranchik, md

Role: primary

alex aviv, md

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 11552770 (View on PubMed)

Other Identifiers

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284

Identifier Type: -

Identifier Source: org_study_id