Amisulpride in Schizophrenic Acute Phase Patients | NCT00436371

Studies
Amisulpride in Schizophrenic Acute Phase Patients

NCT00436371

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 5, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Schizophrenia

Interventions

Amisulpride

Countries

Hong Kong

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

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Nov 2006Actual

Completion Date

Not provided

First Submitted Date

Feb 15, 2007

First Submission Date that Met QC Criteria

Feb 15, 2007

First Posted Date

Feb 19, 2007Estimated

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

Sep 4, 2008

Last Update Posted Date

Sep 5, 2008Estimated

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Amisulpride 400-800mg per day on a twice-a-day regimen	Drug: Amisulpride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amisulpride	Drug	Oral tablets	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		all across the study

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impressions		All accross the study
Patient compliance		all across the study
Percentage of patient completing treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion Criteria:

Patients previously treated with amisulpride
Patients have comorbidity which may interfere with the treatment or follow-up
Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
Pregnant or lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Elaine Tang	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077582	Amisulpride

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided