EUCTR2005-004383-23-GBActive, not recruitingPhase 1
Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics in poorly adherent subjects with schizophrenia ina routine care setting. Protocol RISSCH4055; Phase IV(risperidone microspheres) - Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics
Janssen Cilag Ltd0 sites0 target enrollmentStarted: October 26, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •1) Male or female inpatient or outpatient subjects, aged 18 65 years inclusive
- •2) Diagnosis of schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)39
- •3) Female subjects 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 sterilisation or abstinence) before entry and throughout the study; and have a negative urine pregnancy test at screening before study entry
- •4) Subjects who have had at least 2 hospitalizations or ³ 2 clinical exacerbations (as defined in 3.1) over the past 2 years due to suspected deteriorating adherence
- •5) In the last 5 years, patient must have demonstrated a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) to confirm no treatment resistance.
- •6) Currently on antipsychotic treatment as per local product label guidelines.
- •7) Subjects (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
- •8)Otherwise healthy as confirmed by physical exam, vital signs and laboratory testing.
- •9)Subject has an address and access to a telephone
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •1) Primary DSM-IV TR Axis I diagnosis other than schizophrenia
- •2) Subjects previously treated or currently on clozapine
- •3) Confirmed hypersensitivity or intolerability to risperidone
- •4) Contraindications for use as listed in the product monographs for risperidone, olanzapine, quetiapine, and where commercially available aripiprazole and amisulpride
- •5) Female subjects who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start
- •6) Long acting formulations of neuroleptic medications within 1 treatment cycle of screening
- •7) Subjects who have failed to respond to 2 or more adequate treatment trials of antipsychotics (an adequate trial is defined as 6 weeks of treatment on the maximum local label dose of the antipsychotic) or 1 adequate trial with oral risperidone.
- •8) Laboratory abnormality that is deemed clinically significant by the Investigator
- •9) Serious, unstable and untreated medical illnesses: vascular or cardiovascular disease, history of liver or renal insufficiency, significant cardiac, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances
- •10) Subjects at significant risk of suicide or violence at study start
- •11) Evidence of alcohol or medication abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry
- •12) Treatment with electroconvulsive therapy (ECT) within 2 years of screening
- •13) Have received an experimental medication or used an experimental medical device within 30 days before screening.
- •14) Employees of the investigator or study centre, 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.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics in poorly aderant subjects with schizophrenia ina routine care setting. Protocol RISSCH4055; Phase IV(risperidone microspheres) - Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychoticsSchizophreniaEUCTR2005-004383-23-IEJanssen-Cilag Ltd260
Not yet recruiting
Phase 3
The randomized controlled trial of risperidone in reduction for the incidence of postoperative delirium in patients undergoing vascular surgerypostoperative deliriumRisperidonevascular patientsTCTR20170724002Faculty of Medicine Siriraj Hospital, Mahidol University150
Recruiting
Not Applicable
A randomised controlled trial of the use of a respiratory function monitor to teachneonatal mask ventilation to healthcare professionals in a simulation settingACTRN12616000542493Centre for Research Excellence and Newborn Research Centre, Royal Women's Hospital Melbourne382
Completed
Not Applicable
Response to an invitation to Self-sampling for Human papillomavirus (HPV) versus repeat Invitation for cervical screening in persistent non-responders in NEwcastle upon TyneCervical screeningCancerISRCTN39154605Queen Mary University of London (UK)300
Completed
Not Applicable
PCT of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot StudyKCT0007057Jaseng Hospital of Korean Medicine84