NCT00567203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 2, 2008

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

December 3, 2007

Last Update Submit

October 1, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Positive and Negative Syndrome Scale (PANSS)

    6 days

  • Change from baseline in the CNS Vital Signs Cognition Battery domain scores

    6 days

Study Arms (3)

1

EXPERIMENTAL
Drug: PF-3463275

2

EXPERIMENTAL
Drug: PF-3463275

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-3463275DRUG

PF-3463275 10mg

1
PlaceboDRUG

Placebo

3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

Willingboro, New Jersey, 08046, United States

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

1-methyl-1H-imidazole-4-carboxylic acid (3-chloro-4-fluoro-benzyl)-(3-methyl-3-aza-bicyclo(3.1.0) hex-6-ylmethyl)amide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 4, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 2, 2008

Record last verified: 2008-10

Locations

US(2)