Trials Sponsors Conditions Drugs Pricing

Conditions

Schizophrenia Schizoaffective Disorder Bipolar Disorder

Keywords

schizophreniaschizoaffective disorderbipolar disordermetabolic syndrome

Outcome Measures

Primary Outcomes (1)

Triglyceride/High-density Lipoprotein (TG/HDL) Ratio
24 weeks

Secondary Outcomes (5)

Weight
24 weeks
Body Mass Index (BMI)
24 weeks
Cholesterol
24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

aripiprazole (Abilify)

Drug: aripiprazole (Abilify)

2

ACTIVE COMPARATOR

ziprasidone (Geodon)

Drug: ziprasidone (Geodon)

Interventions

aripiprazole (Abilify)Drug

active drug given daily as per package insert according to standard clinical care for twelve month duration of study. Subject will be switched from current antipsychotic to this drug or other randomized study medication.

ziprasidone (Geodon)Drug

active medication will be given daily as per package insert according to standard clinical care for the twelve month duration of the study. Subject will be switched from current antipsychotic medication to this medication or the other randomized medication.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

To be eligible, a patient must :
Be male or female, between 18-65.

Sponsors & Collaborators

National Alliance for Research on Schizophrenia and Depression
Othercollaborator
Northwestern University
Otherlead

Study Sites (1)

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212, United States

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderMetabolic Syndrome

Interventions

Aripiprazoleziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Results Point of Contact

Title: Dr. Herbert Meltzer
Organization: Northwestern University

Study Officials

Tianlai Tang, M.D.
Vanderbilt University Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations