Study Evaluating Multiple Ascending Dose in Schizophrenia Patients - Full Text View

Sponsors and Collaborators:	Wyeth Solvay Pharmaceuticals
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00620568

Purpose

This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.

Condition	Intervention	Phase
Healthy	Drug: SLV-313 SR	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety Study
Official Title:	An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Observe safety and tolerability [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK and PD profile [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	February 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SLV-313 SR sustained release tablets taken once daily for 14 days
2: Experimental	Drug: SLV-313 SR sustained release tablets taken once daily for 14 days
3: Experimental	Drug: SLV-313 SR sustained release tablets taken once daily for 14 days
4: Experimental	Drug: SLV-313 SR sustained release tablets taken once daily for 14 days

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men, aged 18-50 years old
Women, aged 18-50 years old

Exclusion Criteria:

Non-lactating women, aged 18-50 years old
Non-pregnant women, aged 18-50 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620568

Sponsors and Collaborators

Wyeth

Solvay Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3170A1-1001
Study First Received:	February 8, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00620568 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Safety
Tolerability
Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Healthy
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 04, 2009