Primary objective is to compare all cause discontinuation rates in patients with schizophrenia randomized to either one of the two depot medications (aripiprazole depot or paliperidone palmitate) with patients randomized to either one of the two…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is all cause discontinuation (i.e. discontinuation or switching
of medication, adding a second antipsychotic agent beyond the allowed limit,
patient withdraws consent, patient has missed a monthly visit despite a
reminder).
Secondary outcome
Secondary outcome measures includes scores on the Positive and Negative Symptom
Scale (PANSS), CGI, Personal and Social Performance scale (PSP), Subjective
Wellbeing (SWN), quality of life (EQ-5D), cognitive functioning, prevalence of
aggression incidents, resource utilization and safety measures. In a separate
protocol with a separate consent form, patients will be asked to provide blood
for genetic and immune system analyses.
Background summary
Schizophrenia is a chronic psychiatric illness with periods of remission and
relapse. Patients vary in the frequency and severity of relapse, time until
relapse and time in remission. Discontinuation of antipsychotic medication is
by far the most important reason for relapse. A possible method to optimize
medication adherence is to treat patients with long-term, depot medication
rather than oral medication. However, despite its apparent *common sense* this
approach has neither been universally accepted by practicing psychiatrists nor
unequivocally demonstrated in clinical trials. Therefore, in this study we aim
to investigate possible advantages of depot medication over oral antipsychotics
in an independently designed and conducted, randomized, pragmatic trial.
Study objective
Primary objective is to compare all cause discontinuation rates in patients
with schizophrenia randomized to either one of the two depot medications
(aripiprazole depot or paliperidone palmitate) with patients randomized to
either one of the two oral formulations of the same medication (aripiprazole or
paliperidone) over an 18 month follow-up period. Secondary objectives include
differences in symptom severity, global functioning, quality of life,
psychosocial functioning and side-effects, the a-priori opinion of the patients
and investigators regarding the comparative values of oral vs. depot medication
and safety measures.
Study design
Pragmatic, randomized, open label, multicenter, multinational comparative
trial. One month for the medication switch and a follow-up of 18 months.
Patients asked to participate but having refused at any time before receiving
one dose of trial medication, will be followed with the Clinical Global
Impression list (CGI) as closely related to the study schedule as possible,
unless they also refuse this.
Intervention
Randomization and medication switch (1:1:1:1) to either paliperidone palmitate
or aripiprazole depot or oral aripiprazole or oral paliperidone.
Study burden and risks
Use of the study medication implies that there is a potential for side effects,
as all (antipsychotic) drugs carry the risk of side effects. There is no
additional risk associated with the study procedures. The pragmatic study
design intends to minimize additional time investment from participating
subjects. Potential individual benefits are those associated with the closely
monitored long term treatment of schizophrenia.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of schizophrenia as defined by DSM-IV-R as determined by the M.I.N.I.plus;2. Age 18 or older. ;3. The first psychosis occurred at least 6 months and no more than 7 years ago.;4. If patients are using an antipsychotic drug, a medication switch is currently under consideration.;5. Capable of providing written informed consent
Exclusion criteria
1. Intolerance / hypersensitivity to both* of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/or hypersensitivity to risperidone.
2. Pregnancy or lactation.
3. Patients who are currently using clozapine.
4. Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
5. Patients with a documented history of intolerance to both* of the study medications and/or a documented history of non-response to a treatment with both* study drugs of at least 6 weeks within the registered dose range.
6. Forensic patients.
7. Patients who have been treated with an investigational drug within 30 days prior to screening.
8. Simultaneous participation in another intervention study (neither medication nor psychosocial intervention).
* If intolerance/hypersensitivity or non-response in the past to one of the compounds is documented, the patient can still participate; however, randomization will take place by blocking that specific compound.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002765-30-NL |
| ClinicalTrials.gov | NCT02146547 |
| CCMO | NL49490.041.14 |