The objective of this study is to investigate whether patients with a good premorbid functioning have a beter treatment response after treatment with Risperdal® Consta® than those patients with poor premorbid functioning. Premorbid functioning of…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectise is if patients with a good premorbid functioning have a
better treatment response than patients with a bad premorbid functioning as
measured by the PANSS total score (Positive And Negative Syndrome Scale) and
the CGI-S (Clinical Global Impression of Severity). Changes will be measured
from baseline to total end score.
Secondary outcome
The effectiveness of Risperdal® Consta® will be assessed secundarily as follows:
1. Effectivity: CGI-S/C (Severity & Change), PANSS, GAF (Global Assessment of
Functioning) and patient retention rate in the study;
2. Patient functioning: SF-36 (short-form 36, to be completed by the patient)
and rehospitalization rates;
3. Safety: reported adverse events, ESRS (Extrapyramidal Symptom Rating Scale)
and patient retention rate in the study;
4. Insight: SAI-E (Scale for Assessment of Insight - Expended version) and
PANSS.
Background summary
Schizophrenia is a fundamental disorder in psychosocial functioning and is
generally chronic. Early intervention with the right treatment can positively
influence the disease outcome of schizophrenia or schizoaffective disorder.
Study objective
The objective of this study is to investigate whether patients with a good
premorbid functioning have a beter treatment response after treatment with
Risperdal® Consta® than those patients with poor premorbid functioning.
Premorbid functioning of the patient will be assessed with the PAS score
(Premorbid Adjustment Scale).
Study design
This study is an international, open-label, prospective, multicenter fase IV
study.
Intervention
The treatment with Risperdal® Consta® consists of biweekly intramuscular
injections with risperidon (startingdose 25 mg). The dose may be increased with
an interval of at least 6 weeks and reduced at any time. During the first 3
weeks, patients will be treated with previous antipsychotic mediaction. Prior
to inclusion, treatment naïve patients will receive a test dose of oral
Risperdal® for 2 days.
During the study, patients will visit the investigator 4 times in total,
besides their biweekly treatment, respectively at study entry and subsequently
after 6 weeks, 12 weeks and 26 weeks.
Study burden and risks
Patients eligible for this study, are in need of treatment with antipsychotic
medication for at least 6 months in the opinion of the investigator. The study
burden for the patients have three aspects. Firstly, at the study start en end
a medical examination will take place. Secundly, the patient will visit the
investigator four times. The investigator will complete several questionnaires
and one questionnaire will be completed by the patient following the visits.
These are normal procedures for patients with this indication. Finally, the
patient will receive biweekly Risperdal® Consta® injections.
Postbus 90240
5000 LT
Nederland
Postbus 90240
5000 LT
Nederland
Listed location countries
Age
Inclusion criteria
- Male or female;- Age >18 years;- Primary diagnosis of schizophrenia/schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV-TR).;- Primary diagnosis for less than 2 years following initial diagnosis and treatment.;- At least 2 previous psychotic episodes.;- Maximum total PANSS score of 80.;- Patients who, in the opinion of the investigator, require at least 6 months treatment with antipsychotic medication.;- Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose.;- Female patients must be surgically sterile, or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilization or abstinence) before entry and throughout the study; and have a negative pregnancy test at baseline, before study entry.;- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
- DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.;- Patients already on treatment with Risperdal Consta.;- Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry.;- Pregnant or breast-feeding females.;- Patients who have previously received treatment with clozapine.;- Evidence of alcohol or drug dependence (except for nicotine and caffeine dependence according to DSM-IV-TR criteria diagnosed in the last month prior to entry).;- History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome.;- Known hypersensitivity/intolerance or previous non-response to oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded).;- Patients who are known non-responders to previous treatment with at least 2 antipsychotics.;- Serious, unstable and untreated medical illnesses.;- Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use.;- Patients with mental retardation.;- Known clinically significant ECG abnormality.;- Patients at acute risk of suicide in the investigators opinion at study entry or history of suicidal attempt(s) in the last 3 months before the
study entry.;- Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.;- Patients with known phenylketonuria.;- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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 | EUCTR2005-004621-25-NL |
| CCMO | NL11841.028.06 |