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Add On Treatment for Cognitive Deficits in Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Add On Treatment for Cognitive Deficits in Schizophrenia

A Phase1B Study: A Placebo Controlled Study of PF-03654746 Given as Add-On Treatment of Cognitive Deficits in Schizophrenia

NCT01346163•University of Pennsylvania

View on ClinicalTrials.gov

Summary

This study will look at the impact of dosing as well as ongoing treatment with an investigation medication identified as PF-03654746, on cognitive and physiologic indicators of brain function. Data from this study will assist with the evaluation of the utility of functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic measures in the detection of early signals of the effectiveness of medications developed to target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this population will be also be evaluated.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must be competent to provide informed consent to participate in a clinical trial before any trial-related procedures can take place;
•2. Subjects must be willing and able to comply with scheduled visits, treatments, laboratory tests and other testing and study procedures;
•3. Subjects who participate must be willing to remain in-patient for at least one week at the beginning of each treatment period and remain in the hospital until judged by the Investigator to be clinically stable and able to be discharged to outpatient status;
•4. Subjects must be fluent in English and able to understand all study related materials;
•5. Subjects must be between the ages of 18-40 (inclusive) and if Female be of non-childbearing potential;
•6. Body Mass Index (BMI) 18 to 40 kg/m2 and a total body weight of at least 50 kg (110 lbs);
•1. Subjects must have a current DSM-IV-TR diagnosis of schizophrenia of Paranoid (295.30), Disorganized (295.10), Undifferentiated (295.90) or Residual Type (295.60);
•2. Subjects must be receiving ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone or aripiprazole;
•3. Subjects must be on a stable medication treatment regimen 2 months, including concomitant psychotropic medications;
•4. Evidence of stable control of symptoms for 3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia);
+8 more criteria

Exclusion Criteria

•1. Female subjects who still have child bearing potential and females who are breastfeeding;
•2. History of febrile illness within 5 days prior to the first dose;
•3. Any condition possibly affecting drug absorption (eg, gastrectomy);
•4. Subjects who have a positive urine drug screen which cannot be explained by prescribed medications;
•5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening;
•6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication;
•7. 12-lead ECG demonstrating QTc less than or equal to 450 msec at screening;
•8. Subjects who are using disallowed concomitant medications and who will not be able to discontinue these concomitant medications prior to randomization;
•9. Subjects who have taken hormone replacement therapy within 28 days or have taken an herbal remedy 7 days prior to the first dose of trial medication;
•10. Subjects with other conditions that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and in the judgment of the Investigator, would make the subject inappropriate for entry into this trial;
+29 more criteria

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

May 2, 2011

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

PF 03654746

DRUG

Placebo

OTHER

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Add On Treatment for Cognitive Deficits in Schizophrenia

Inclusion Criteria

Exclusion Criteria

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