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SchizophreniaPhase 4PROACTIVENCT00330863

Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

A Phase 4 study testing Risperidone microspheres, Risperidone and Olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
Risperidone microspheres, Risperidone and Olanzapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
357 participants
Where
8 sitesUnited States
Study dates
May 2006to Jan 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All schizophrenia and schizoaffective patients whose clinicians are considering long-term treatment with an "atypical" (second generation) antipsychotic medication
  • Worsening of illness (schizophrenia) within 12 months of study entry as defined by: hospitalization, increased level of clinical care, and/or present clinical Global Impressions Severity rating of moderate or worse

Who cannot join

  • First episode patients as defined by a patient who: has never received antipsychotic medication and has never been hospitalized for psychiatric illness; or, is receiving antipsychotic medication for the first time associated with a first diagnosis of schizophrenia.
  • Pregnant or breastfeeding
  • Patients with unstable medical conditions
  • Patients with previous history of failure to respond to an adequate trial of clozapine
  • Patients with a known allergy to risperidone or a previous history of failure to respond to an adequate trial of risperidone. However, patients with known allergies or failure to respond to any of the other medications (aripiprazole, olanzapine, quetiapine or ziprasidone) will not receive that medication if they are randomized to the oral medication arm, but are not excluded from the study

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Medical College of Georgia, Department of Psychiatry

    Augusta, Georgia, 30912-3800

  • Harvard Medical School -- Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center

    Fall River, Massachusetts, 02720

  • The Zucker Hillside Hospital

    Glen Oaks, New York, 11004

  • University of Iowa College of Medicine, Psychiatry Research

    Iowa City, Iowa, 52242

  • University of California, Los Angeles

    Los Angeles, California, 91344

  • Creighton University

    Omaha, Nebraska, 68131

Other trials in United States

About this study

Official title: Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms.

Read the detailed description

As is the case with many chronic illnesses, it can be challenging for people with schizophrenia to take multiple pills every day on a long-term basis. At the same time, missing or discontinuing the anti-psychotic medications that treat schizophrenia substantially increases the risk of relapse and re-hospitalization. This study will determine how effective long-acting injectable risperidone is compared to oral antipsychotic medications to help patients who have schizophrenia. Patients who enroll in the study will be randomly assigned to receive either long-acting injectable risperidone or to receive oral "atypical" antipsychotic medication. The "atypical" antipsychotics that are included for patients in the oral group are: aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. Patients in the "oral" group will receive whichever of the five "atypical" antipsychotic medications they and their study doctor decide is best for them. Patients in the "oral" group will be allowed to switch to others of the five medications during the study if they and their doctor think that is best.

Patients in this study will be evaluated at the beginning of the study and then again every two weeks for up to 30 months (2 1/2 years). Each two-week visit will take about 20 minutes. At the visit, patients will receive medication and will be examined for side effects of the medications, their vital signs (heart rate, blood pressure, weight, and waist measurement) will be measured, and they will be asked a few questions about attendance at visits and taking medication. The visit that occurs every three months will take about one hour, instead of 20 minutes, and will include additional questions, an examination for muscle stiffness or abnormal body movements, and an interview from a member of the research team conducted using computer technology. In addition, blood and urine samples may be collected about seven times throughout the 30 months of the study treatment. Patients who enroll in this study after the halfway point of the study, may not receive a full 30 months of treatment, but it is planned that all patients will have the opportunity to receive no less than 18 months of treatment.

Being tested
Risperidone microspheres, Risperidone, Olanzapine, Quetiapine, Ziprasidone
Keywords
Relapse, Prevention, Schizophrenia, Injectable Medication
Medical subject headings
Schizophrenia, Psychotic Disorders, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risperidone microspheresDrug

    Also called Risperdal Consta

    Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.

  • RisperidoneDrug

    Also called Risperdal

    Target dose is 4 mg/day.

  • OlanzapineDrug

    Also called Zyprexa

    Target dose is 15 mg/day.

  • QuetiapineDrug

    Also called Seroquel

    Target dose is 600 mg/day.

  • ZiprasidoneDrug

    Also called Geodon

    Target dose is 120 mg/day.

  • AripiprazoleDrug

    Also called Abilify

    Target dose is 20 mg/day.

  • PaliperidoneDrug

    Also called Invega

    Target dose is 6 mg/day.

Study groups in NCT00330863
Study groupRoleWhat they receive
InjectableExperimentalParticipants assigned to receive long-acting injectable risperidone
Receives: Drug: Risperidone microspheres
OralActive comparatorParticipants assigned to receive oral "atypical" antipsychotic medication
Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Ziprasidone; Drug: Aripiprazole; Drug: Paliperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substantial Clinical Deterioration Measured by Psychotic Symptoms

    Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.

    Measured: Measured throughout study up to 30 months

Secondary outcomes (5)

  1. Number of Patients Discontinuing From the Study

    Measured: Measured throughout study up to 30 months

  2. Number of Days in Hospital

    Measured: Measured throughout study up to 30 months

  3. Control of Psychiatric Symptoms

    Brief Psychiatric Rating Scale (BPRS) total score

    Measured: Measured throughout study up to 30 months

  4. Quality of Life Measures

    Scale of Functioning (SOF)

    Measured: Measured throughout study up to 30 months

  5. Side Effects and Metabolic Measures

    The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.

    Measured: Measured throughout study up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00330863
Sponsor's protocol ID
U01MH070007-01
Other IDs
U01MH070007-01, U01MH070023, U01MH070011, U01MH070009, U01MH070008, U01MH070017, U01MH070010, U01MH070016
Acronym
PROACTIVE
Status last verified
Jun 2018
First submitted
26 May 2006
Last updated
10 Jul 2018
Data monitoring committee
Yes

Publications

  • Buckley PF, Schooler NR, Goff DC, Hsiao J, Kopelowicz A, Lauriello J, Manschreck T, Mendelowitz AJ, Miller del D, Severe JB, Wilson DR, Ames D, Bustillo J, Mintz J, Kane JM; PROACTIVE Study. Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study. Schizophr Bull. 2015 Mar;41(2):449-59. doi: 10.1093/schbul/sbu067. Epub 2014 May 27.

    PubMed 24870446

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risperidone microspheres, Risperidone and Olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substantial Clinical Deterioration Measured by Psychotic Symptoms (time frame: Measured throughout study up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00330863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.

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