NCT00222833

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

September 7, 2005

Last Update Submit

January 8, 2008

Conditions

OverweightHyperlipidemiaCardiovascular Diseases

Keywords

SchizophreniaSchizoaffective disorderAripiprazoleObeseOverweightHeart HealthAntipsychoticHeart Health FactorsCardiovascular Health IndicesCardiovascular health

Outcome Measures

Primary Outcomes (1)

  • To examine heart health factors: serum lipids, serum leptin, fasting blood glucose, body weight, and blood pressure

Secondary Outcomes (6)

  • Changes in clinical state

  • Pre-existing or emergent side effects

  • Cognition and insight

  • Attitude towards medication

  • Social functioning

  • +1 more secondary outcomes

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

OverweightHyperlipidemiasCardiovascular DiseasesSchizophreniaPsychotic DisordersObesity

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Rohan Ganguli, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(1)