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Could a medication switch improve schizophrenia treatment?

NCT ID NCT00232687

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study looks at switching from risperidone to aripiprazole (Abilify) in people with schizophrenia who are not getting enough symptom relief or are having side effects from risperidone. Participants are randomly assigned to one of two ways to switch medications over 12 weeks. The goal is to see which switching method is safer and better tolerated.

What this could mean

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

Active substance
aripiprazole (Abilify)
What this could lead to
If successful, this could offer a better-tolerated treatment option for people with schizophrenia who struggle with their current medication.
What could go wrong
This is a phase 4 study comparing two switching strategies, not a test of a new drug. Results may not apply to all patients, and side effects from aripiprazole are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

450 people

The number who actually took part.

Started

Jun 2005

Finished

Apr 2007

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria * Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone * Men and women, aged 18 - 65 years Exclusion Criteria: * Patients who are at risk for committing suicide * Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes * Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening * Treatment-resistant to antipsychotic medication

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

  • Local Institution

    Hall in Tirol, Austria

  • Local Institution

    Vienna, Austria

  • Local Institution

    Bruges, Belgium

  • Local Institution

    Brussels, Belgium

  • Local Institution

    Diest, Belgium

  • Local Institution

    Halle, Belgium

  • Local Institution

    Sint-Denijs-Westrem, Belgium

  • Local Institution

    Stokrooie, Belgium

  • Local Institution

    Havířov, Czechia

  • Local Institution

    Olomouc, Czechia

  • Local Institution

    Prague, Czechia

  • Local Institution

    Přerov, Czechia

  • Local Institution

    Aubagne, France

  • Local Institution

    Bordeaux, France

  • Local Institution

    Brumath, France

  • Local Institution

    Château-Gontier, France

  • Local Institution

    Clermont-Ferrand, France

  • Local Institution

    Dijon, France

  • Local Institution

    Dommartin-lès-Toul, France

  • Local Institution

    Fains-Véel, France

  • Local Institution

    Hénin-Beaumont, France

  • Local Institution

    Le Pecq, France

  • Local Institution

    Lyon, France

  • Local Institution

    Poitiers, France

  • Local Institution

    Reims, France

  • Local Institution

    Roubaix, France

  • Local Institution

    Toulon, France

  • Local Institution

    Toulouse, France

  • Local Institution

    Achim, Germany

  • Local Institution

    Bochum, Germany

  • Local Institution

    Cologne, Germany

  • Local Institution

    Ellwangen, Germany

  • Local Institution

    Hattingen, Germany

  • Local Institution

    Nuremberg, Germany

  • Local Institution

    Osnabrück, Germany

  • Local Institution

    Ostfildern, Germany

  • Local Institution

    Witten, Germany

  • Local Institution

    Athens, Greece

  • Local Institution

    Chania, Greece

  • Local Institution

    Corfu, Greece

  • Local Institution

    Kalymnos, Greece

  • Local Institution

    Thessaloniki, Greece

  • Local Institution

    Tripoli, Greece

  • Local Institution

    Baja, Hungary

  • Local Institution

    Eger, Hungary

  • Local Institution

    Esztergom, Hungary

  • Local Institution

    Kistarcsa, Hungary

  • Local Institution

    Pécs, Hungary

  • Local Institution

    Sopron, Hungary

  • Local Institution

    Sestri Ponente, Genova, Italy

  • Local Institution

    Aosta, Italy

  • Local Institution

    Bolzano, Italy

  • Local Institution

    Foggia, Italy

  • Local Institution

    L’Aquila, Italy

  • Local Institution

    Milan, Italy

  • Local Institution

    Roggiano Gravina, Italy

  • Local Institution

    Roma, Italy

  • Local Institution

    Terrassa, Barcelona, Spain

  • Local Institution

    Barcelona, Spain

  • Local Institution

    Elche, Spain

  • Local Institution

    Langreo, Spain

  • Local Institution

    Madrid, Spain

  • Local Institution

    Murcia, Spain

  • Local Institution

    Oviedo, Spain

  • Local Institution

    Salamanca, Spain

  • Local Institution

    Valencia, Spain

  • Local Institution

    Zamora, Spain

  • Local Institution

    Newport, Gwent, United Kingdom

  • Local Institution

    South Wales, Mid Glamorgan, United Kingdom

  • Local Institution

    Hull, North Yorkshire, United Kingdom

  • Local Institution

    Dundee, Tayside, United Kingdom

  • Local Institution

    Haywards Heath, West Sussex, United Kingdom

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