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Heart risk check for schizophrenia drugs

NCT ID NCT00288353

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see how two antipsychotic drugs, aripiprazole and ziprasidone, affect heart risk in people with schizophrenia, schizoaffective disorder, or bipolar disorder. Researchers measured blood fats and heart electrical changes in 48 adults over 12 months. The trial was stopped early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aripiprazole and ziprasidone
What this could lead to
If successful, this could help doctors choose antipsychotics that lower heart risk in patients with schizophrenia or bipolar disorder.
What could go wrong
This small, terminated Phase 3 trial may not provide clear results due to early stopping, and findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

48 people

The number who actually took part.

Start date

Jan 2006

Finished

Dec 2008

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria To be eligible, a patient must : * Be male or female, between 18-65. * Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual (DSM-IV) criteria * Have TG/HDL ratios (\>\>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina * Be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone * Be willing to change current antipsychotic medication to that chosen by the principal investigator * Have a history of compliance with the above medication * Be Medicaid eligible or maintain insurance covering requested lab procedures * Be able to provide written informed consent. Exclusion criteria A patient will be considered ineligible if he/she: * Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria. * Has a history of noncompliance with prescribed psychiatric medications * Has a TG/HDL ratio \< 3.5 on current medication * Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance. * Is unable to provide written informed consent. * (Females only) Is pregnant, lactating or plans to become pregnant during study participation

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Conditions

The condition(s) this trial relates to.

bipolar disorder metabolic syndrome X Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder Schizoaffective disorder Schizophrenia

Contacts and locations

Locations

  • Vanderbilt Psychiatric Hospital

    Nashville, Tennessee, 37212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.