Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
The purpose of this research study is to compare the real-world effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).
Detailed description
The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule. This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.
Interventions
haloperidol decanoate injections, 25-200 mg once a month
DRUGpaliperidone palmitate
Paliperidone palmitate injections, 39 mg - 234 mg once a month
Sponsors
National Institute of Mental Health (NIMH)
Duke University
University of North Carolina, Chapel Hill
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria * Age 18-65 years * Capacity to provide informed consent * Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate * Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.
Exclusion criteria
* Patients who are currently stable and doing well on an antipsychotic regimen * Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol * Patients with tardive dyskinesia that is moderate or severe * Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study * Women who are pregnant or breastfeeding * Patients with mental retardation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Failure | 24 months | Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Psychiatric Symptoms | Baseline to 6 months | The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Palmitate Intramuscular injections of paliperidone palmitate 39-234 mg every month | 145 |
| Haloperidol Decanoate Intramuscular injections of haloperidol decanoate 25-200 mg every month | 145 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 14 | 12 |
| Overall Study | Adverse Event | 15 | 14 |
| Overall Study | Did not follow up after first injection | 2 | 2 |
| Overall Study | Did not receive injection | 10 | 7 |
| Overall Study | Lack of Efficacy | 42 | 39 |
| Overall Study | Withdrawal by Subject | 33 | 36 |
Baseline characteristics
| Characteristic | Paliperidone Palmitate | Haloperidol Decanoate | Total |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 12.6 | 45 years STANDARD_DEVIATION 12.3 | 44 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 39 Participants | 35 Participants | 74 Participants |
| Sex: Female, Male Male | 106 Participants | 110 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 100 / 147 | 88 / 147 |
| serious Total, serious adverse events | 53 / 147 | 45 / 147 |
Outcome results
Primary
Efficacy Failure
Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
Time frame: 24 months
Population: All randomized participants who received an injection and attended one follow-up appointment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Palmitate | Efficacy Failure | 49 participants |
| Haloperidol Decanoate | Efficacy Failure | 47 participants |
Secondary
Changes in Psychiatric Symptoms
The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.
Time frame: Baseline to 6 months
Population: Participants with PANSS scores at 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paliperidone Palmitate | Changes in Psychiatric Symptoms | -6.87 Units on a scale |
| Haloperidol Decanoate | Changes in Psychiatric Symptoms | -6.40 Units on a scale |