Clinical trial NCT01698216: Switching From Consta® to Sustenna® in Patients With Schizophrenia
Official title: Switching From Risperidone Long Acting Injection (Consta®) to Paliperidone Palmitate (Sustenna®) in Patients With Schizophrenia and Its Influence on Subjective Well-Being: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Paliperidone
Palmitate
switching
schizophrenia
subjective well-being
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection

Brief summary: The aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.

Detailed description: In this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. And investigators will examine the effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side effect related variables will be studied.

Eligibility criteria: Inclusion Criteria:

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* Maintenance therapy more than 6 months with Risperidone Long Acting Injection monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone Long Acting Injection was maintained 8 weeks more. The stable dose of other antipsychotics has been maintained 8 months and more.
* Patient wants to switch antipsychotics to Paliperidone Palmitate.
* PANSS total score ≤ 80
* Each score of conceptual disorganization(P2), hallucinatory behavior(P3), Suspiciousness/persecution(P6), unusual thought content(G9)in PANSS ≤ 4
* Competent patient who is manage to answer the questionnaires.
* In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

* No history of antipsychotics use.
* Past history of NMS.
* Allergy or hypersensitivity to Risperidone or Paliperidone ER.
* Concomitant antipsychotics was oral Risperidone or Paliperidone ER.
* Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study)
* Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other mood stabilizer within 2months (maintenance is allowed).
* Patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion.
* Current substance dependence(DSM-IV) or past history of dependence (more than 6months)
* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion.
* History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of QT prolonging drugs
* Pregnant or breast-feeding female patient.
* History of participating to other investigational drug trial within 1month prior to screening.
* Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Primary outcomes:
measure: Subjective Well-being Under Neuroleptic Treatment (SWN)
timeFrame: Change from Baseline in SWN score at 108 weeks
Secondary outcomes:
measure: Korean Drug Attitude Inventory-10
timeFrame: Change from Baseline in score at 108 weeks
measure: Positive and Negative Syndrome Scale
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Clinical Global Impression-Severity, Improvement
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Personal and Social Performance Scale
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Symptom Check List-90-Revised
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Drug-Induced ExtraPyramidal Symptoms Scale
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Liverpool University Neuroleptic Side Effect Rating Scale
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Visual Analog Scale
timeFrame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: ECG
timeFrame: 8, 24, 48, 72, 108 week
measure: blood pressure
timeFrame: 0,4,8,16,24,48,72,108 week
measure: Body weight
timeFrame: 0,4,8,16,24,48,72,108 week
measure: waist circumference
timeFrame: 0,4,8,16,24,48,72,108 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: