Reboxetine Adjuvant Therapy for the Treatment of Schizoph... | NCT00409201

Studies
Reboxetine Adjuvant Therapy for the Treatment of Schizophrenia

NCT00409201

Sponsor

Abarbanel Mental Health Center

Status

Unknown status

Last Update Posted

Dec 8, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Schizophrenia

Interventions

reboxetine adjuvant therapy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 7, 2006

First Posted Date

Dec 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2006

Last Update Posted Date

Dec 8, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
reboxetine adjuvant therapy	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sans, panss, hamilton, ham-a, calgary, physical examination, cogscan test

Secondary Outcomes

Measure	Description	Time Frame
esrs, progesterom, sexual functioning, covy, cgi, cgi improved

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

schizophrenia all types
18>

Exclusion Criteria:

uti
>65
non organic state
no depression treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
stanislav baranchik, md	Contact	972-3-5552625

Overall Officials

Name	Affiliation	Role
stanislav baranchik, md	abarbanel mhc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abarbanel Medical Mental Health Center	Recruiting	Bat Yam		59100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11552770	Background	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.

ID	Term
D012559	Schizophrenia
D001519	Behavior

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders