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SchizophreniaNCT00211302

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

A study testing aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
aripiprazole
How many people
8 participants
Where
1 siteUnited States
Study dates
Aug 2003to Feb 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients:
  • Any comorbid major psychiatric diagnoses (major depressive disorder, obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, any disorder with psychosis other than those used as inclusion criteria, bipolar disorder).
  • 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.
Show all 34Show fewer
  • 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.
  • Controls:
  • Current treatment with any psychotropic or anticholinergic medication.
  • Any major psychiatric diagnoses (major depressive disorder, obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, any disorder with psychosis, bipolar disorder, attention-deficit/hyperactivity, learning or developmental disorder).
  • Any significant 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.
  • Any active alcohol or substance dependence in the past six weeks.
  • Significant alcohol or substance abuse in the past six weeks, or alcohol or substance dependence in the past year (as defined by DSM-IV).
  • Inability to understand the purpose of the study and give consent.
  • Significant abnormalities on physical/neurological examination.
  • Subject is hearing impaired.
  • Subject is left-handed.
  • Pregnant or lactating women.
  • Women of childbearing potential not using medically accepted means of contraception (e.g., IUD, birth control pills, barrier devices, implanted hormones).
  • Dropout criteria: subjects that begin the study and are not able to finish the study will be tracked. Ongoing criteria for termination from the study will include:
  • Adverse events that are intolerable to the patient that prevent continued involvement in the study.
  • New onset medical disorder of such significance as to prohibit further involvement.
  • New onset major psychiatric disorder.
  • Initiation or recurrence of alcohol or substance abuse/dependence.
  • Subject withdraws consent for any reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Psychopharmacology Research Clinic

    Shreveport, Louisiana, 71103

Other trials in United States

About this study

Official title: Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia. (BMS)

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.

Read the detailed description
  • Long-range goal is to understand how the schizophrenic brain is abnormal, as well as how the function of the brain changes in response to antipsychotic medication, to better understand and effectively treat disorders with these drugs. This information can be used in other disorder as well, as there are many psychiatric disorders that are targeted by the newer atypical antipsychotics.
  • The objective of this application, which is the next step in pursuit of the long-range goal, is to compare response on a series of cognitive tests (verbal learning, working memory, and attention) and changes in brain activity in a group of patients with schizophrenia or schizoaffective disorder who are taking risperidone, olanzapine, or risperidone Consta injections and who switch to aripiprazole, and in a group of normal control subjects evaluated twice to control for learning effects.
  • The central hypothesis of this application is that patients with schizophrenia or schizoaffective disorder that are taking aripiprazole will have improvements in cognition consistent with the medication's efficacy. We expect that changes in brain activity (from fMRI and EEG) will be correlated with this improvement, as determined by performance on cognitive tests. Further, changes in regional connectivity of affected brain regions will reflect these specific cognitive changes related to aripiprazole.
  • The rationale for this proposed study is that, once we have a better understanding of which drugs improve cognition and what brain regions respond differently to aripiprazole and risperidone, olanzapine, or risperidone Consta, we will have a better understanding of the functional differences tied to the differential actions of the drugs. This is important, because we really don't understand how these medications affect cognition.
Being tested
aripiprazole
Keywords
Cognition, Schizophrenia, Schizoaffective disorder
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aripiprazoleDrug

    Also called Abilify

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI

    Measured: at Week 2 and Week 16

  2. SAM-BFT + cognitive tests

    Measured: at Week 3 and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Why it stopped: Enrollment too difficult

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00211302
Sponsor's protocol ID
LSUHSC #H04-022
Status last verified
Sep 2011
First submitted
13 Sep 2005
Last updated
7 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Enrollment too difficult). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI (time frame: at Week 2 and Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00211302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.

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