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Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

reboxetine adjuvant therapy

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, reboxetine, cognitive, behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

schizophrenia all types
18>

Exclusion Criteria:

uti
>65
non organic state
no depression treatment

Sites / Locations

Abarbanel Medical Mental Health CenterRecruiting
Abarbanel Medical Mental Health CenterRecruiting

Outcomes

Primary Outcome Measures

sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test

Secondary Outcome Measures

esrs, progesterom, sexual functioning, covy, cgi, cgi improved

Full Information

NCT ID

NCT00409201

First Posted

December 7, 2006

Last Updated

December 7, 2006

Sponsor

Abarbanel Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT00409201

Brief Title

Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abarbanel Mental Health Center

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

schizophrenia, reboxetine, cognitive, behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

reboxetine adjuvant therapy

Primary Outcome Measure Information:

Title

sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test

Secondary Outcome Measure Information:

Title

esrs, progesterom, sexual functioning, covy, cgi, cgi improved

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: schizophrenia all types 18> Exclusion Criteria: uti >65 non organic state no depression treatment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

stanislav baranchik, md

Phone

972-3-5552625

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

stanislav baranchik, md

Organizational Affiliation

abarbanel mhc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abarbanel Medical Mental Health Center

City

Bat Yam

ZIP/Postal Code

59100

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

stanislav baranchik, md

Phone

972-3-5552625

First Name & Middle Initial & Last Name & Degree

alex aviv, md

Phone

972-3-552703

alexaviv@gmail.com

First Name & Middle Initial & Last Name & Degree

stanislav baranchik, md

Facility Name

Abarbanel Medical Mental Health Center

City

Bat Yam

ZIP/Postal Code

59100

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

stanislav baranchik, md

12. IPD Sharing Statement

Citations:

PubMed Identifier

11552770

Citation

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.

Results Reference

background

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Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

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