Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)
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| ClinicalTrials.gov Identifier: NCT00330863 |
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Recruitment Status :
Completed
First Posted : May 29, 2006
Results First Posted : July 10, 2018
Last Update Posted : July 10, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Schizoaffective Disorder | Drug: Risperidone microspheres Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Drug: Ziprasidone Drug: Aripiprazole Drug: Paliperidone | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 357 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Injectable
Participants assigned to receive long-acting injectable risperidone
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Drug: Risperidone microspheres
Minimum dose is 12.5 mg every 2 weeks. Maximum dose is 75 mg every 2 weeks.
Other Name: Risperdal Consta |
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Active Comparator: Oral
Participants assigned to receive oral "atypical" antipsychotic medication
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Drug: Risperidone
Target dose is 4 mg/day.
Other Name: Risperdal Drug: Olanzapine Target dose is 15 mg/day.
Other Name: Zyprexa Drug: Quetiapine Target dose is 600 mg/day.
Other Name: Seroquel Drug: Ziprasidone Target dose is 120 mg/day.
Other Name: Geodon Drug: Aripiprazole Target dose is 20 mg/day.
Other Name: Abilify Drug: Paliperidone Target dose is 6 mg/day.
Other Name: Invega |
- Substantial Clinical Deterioration Measured by Psychotic Symptoms [ Time Frame: Measured throughout study up to 30 months ]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.
- Number of Patients Discontinuing From the Study [ Time Frame: Measured throughout study up to 30 months ]
- Number of Days in Hospital [ Time Frame: Measured throughout study up to 30 months ]
- Control of Psychiatric Symptoms [ Time Frame: Measured throughout study up to 30 months ]Brief Psychiatric Rating Scale (BPRS) total score
- Quality of Life Measures [ Time Frame: Measured throughout study up to 30 months ]Scale of Functioning (SOF)
- Side Effects and Metabolic Measures [ Time Frame: Measured throughout study up to 30 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330863
| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 91344 | |
| United States, Georgia | |
| Medical College of Georgia, Department of Psychiatry | |
| Augusta, Georgia, United States, 30912-3800 | |
| United States, Iowa | |
| University of Iowa College of Medicine, Psychiatry Research | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Harvard Medical School -- Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| The Zucker Hillside Hospital | |
| Glen Oaks, New York, United States, 11004 | |
| Study Director: | Nina R. Schooler, PhD | Steering and Implementation Center |
| Responsible Party: | Northwell Health |
| ClinicalTrials.gov Identifier: | NCT00330863 |
| Other Study ID Numbers: |
U01MH070007-01 ( U.S. NIH Grant/Contract ) U01MH070007-01 ( U.S. NIH Grant/Contract ) U01MH070023 ( U.S. NIH Grant/Contract ) U01MH070011 ( U.S. NIH Grant/Contract ) U01MH070009 ( U.S. NIH Grant/Contract ) U01MH070008 ( U.S. NIH Grant/Contract ) U01MH070017 ( U.S. NIH Grant/Contract ) U01MH070010 ( U.S. NIH Grant/Contract ) U01MH070016 ( U.S. NIH Grant/Contract ) U01MH070012 ( U.S. NIH Grant/Contract ) DSIR 83-ATAP ( Other Grant/Funding Number: National Institute of Mental Health ) |
| First Posted: | May 29, 2006 Key Record Dates |
| Results First Posted: | July 10, 2018 |
| Last Update Posted: | July 10, 2018 |
| Last Verified: | June 2018 |
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Relapse Prevention Schizophrenia Injectable Medication |
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Recurrence Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Disease Attributes Pathologic Processes Olanzapine Risperidone Aripiprazole Quetiapine Fumarate Paliperidone Palmitate Ziprasidone Serotonin Antagonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |