A Study Of Adjunctive Treatment Of Cognitive Deficits In... | NCT00567203

Studies
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

NCT00567203

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 2, 2008Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

PF-3463275
PF-3463275
Placebo

Countries

United States

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

Oct 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

Nov 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 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

Oct 1, 2008

Last Update Posted Date

Oct 2, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.

Detailed Description

Not provided

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: PF-3463275
2	Experimental	Drug: PF-3463275
3	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-3463275	Drug	PF-3463275 10mg	1
PF-3463275

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the CNS Vital Signs Cognition Battery composite score		6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.		38 days
Pharmacokinetics of PF-3463275		6 days

Secondary Outcomes

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS)		6 days
Change from baseline in the CNS Vital Signs Cognition Battery domain scores		6 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of schizophrenia
In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
Stable symptoms of schizophrenia for at least 3 months.

Exclusion Criteria:

Subjects with a psychiatric disorder other than schizophrenia
Substance dependence or abuse
Women who have child bearing potential.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Glendale	California	91206	United States
Pfizer Investigational Site

References Module

Citations

Not provided

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