Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS)

NCT00211302 | Terminated

• 1 other identifier: LSUHSC #H04-022
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder both before and after a switch from risperidone to aripiprazole may reveal some of the cognitive changes that correlate with the improved response, better side effect profile, and effects on other components of the negative symptom array. Further, examination of brain functional activity using functional magnetic resonance imaging (fMRI) during a verbal learning task, as well as behavioral performance and associated electroencephalographic (EEG) data of episodic memory, working memory and intermediate term verbal memory collected with the Sustained Attention and Memory Brain Function Test (SAM-BFT), may also provide data showing the neural correlates of these changes in cognition.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Cognition; Schizophrenia; Schizoaffective disorder

Outcome Measures

Primary Outcomes (2)

• fMRI

  at Week 2 and Week 16

• SAM-BFT + cognitive tests

  at Week 3 and Week 16

Interventions

aripiprazole DRUG

10-15 mg/day; if needed, dosage may be increased to 30 mg/day after week 2; maintenance 15 mg/day; periodically reassessed

Also known as: Abilify

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (n=10):
• All patients included in the study will have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder. Outpatients with schizophrenia (DSM-IV 295.00, 295.10, 295.30, 295.60, 295.90) or schizoaffective disorder (DSM-IV 295.70) will be the primary source of subjects for this project, although inpatients that are being discharged will also be acceptable. All patients will be followed longitudinally.
• Patients who are from 18-65 years of age will be accepted.
• Patients will be screened for medical and psychiatric diagnoses.
• At the time of examination and testing, patients must be stable and taking either olanzapine 10 mg per day for at least two weeks, or at least 2 mg of risperidone per day for at least two weeks, or on risperidone Consta injections (at least 25 mg every two weeks) and not taking an anticholinergic medication for at least one week.
• While recruiting stable patients for this study, this does not necessarily mean free of side effects or free of symptoms of schizophrenia or schizoaffective disorder. Patients that express a desire to switch to aripiprazole may be having side effects, or may be worried that increasing the dose of their current medication may cause side effects.
• Controls (n=10):
• The normal control group will provide images of normal response on the behavioral and functional measures, as well as control for the scan-rescan (learning, novelty) effects. They will be matched for age, sex, handedness, and level of education with the patients. They will be screened for medical and psychiatric diagnoses.

You may not qualify if:

• Patients:
• Any significant or unstable medical disorder (including unstable or uncontrolled diabetes; long term, severe, or uncontrolled hypertension; or any neurological disorder). Clinical judgment will be used on a case-by-case basis. Special care will be taken in examining patients for metabolic disturbances such as hyperglycemia or hyperlipidemia, due to the increased risk of these problems related to the use of antipsychotics. Subjects with clinically unstable and markedly abnormal metabolic profiles will be excluded.
• Active alcohol or substance dependence.
• Significant alcohol or substance abuse in the past six weeks or alcohol or substance dependence in the past year (as defined by DSM-IV).
• Unable to speak, read and understand English, or if the study doctor thinks that the patient cannot follow the study procedures.
• Inability to understand the purpose of the study and give consent.
• Subject is hearing impaired.
• Subject is left-handed.
• Significant abnormalities on physical/neurological examination not consistent with an inclusive diagnosis.
• Current treatment with a classical antipsychotic medication.
• Current treatment with an anticholinergic medication.
• History of adverse response or previous lack of response to aripiprazole.
• Pregnant or lactating women.
• Women of childbearing potential not using medically accepted means of contraception (e.g., intrauterine device \[IUD\], birth control pills, barrier devices, implanted hormones).
• Handedness will be tracked, and left-handed patients will be excluded due to the small sample size and the variance this will add to cognitive testing.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Psychopharmacology Research Clinic

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• James C Patterson, MD, PhD

  LSU Health Sciences Center-Shreveport/Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2003
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

US (1)