Clinical trial NCT00222833: The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia
Official title: The Effect of Switching to Aripiprazole on Indices of Cardiovascular Health in Overweight and Obese Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Hyperlipidemia
Cardiovascular Diseases
Keywords: Schizophrenia
Schizoaffective disorder
Aripiprazole
Obese
Overweight
Heart Health
Antipsychotic
Heart Health Factors
Cardiovascular Health Indices
Cardiovascular health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 2-year study proposing to examine the effects of aripiprazole on heart health factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to aripiprazole with respect to changes in the clinical state, preexisting or emergent side-effects, how the brain processes information and changes in social functioning and quality of life.

Detailed description: This is a 2-yr study proposing to examine the effects of switching subjects from conventional and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in overweight and obese patients with Schizophrenia or Schizoaffective disorder. Thirty partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined cross-tapering approach.The objective of the study is to examine cardiovascular health indices such as serum lipids, serum leptin, fasting blood sugar, body weight and blood pressure. This study also examines the safety of switching to Aripiprazole with respect to changes in clinical state, preexisting or emergent side-effects, how brain processes information and changes in social functioning and quality of life.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects ages 18-65 years
* Outpatients and stable partial hospital patients
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
* No psychiatric hospitalization in 30 days prior to study start
* Partially remitted patients with a PANSS score below 100 at screening
* Currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
* Currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
* BMI greater than 26
* Female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
* Ability to provide informed consent.

Exclusion Criteria:

* Mental retardation
* Current treatment with clozapine
* Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
* Serious or unstable medical illness
* Female patients who are pregnant, lactating, or plan to become pregnant during the study period
* Concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.

Primary outcomes:
measure: To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure
Secondary outcomes:
measure: Changes in clinical state
measure: Pre-existing or emergent side effects
measure: Cognition and insight
measure: Attitude towards medication
measure: Social functioning
measure: Quality of life
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rohan Ganguli, MD
role: PRINCIPAL_INVESTIGATOR
References: