Switching From Consta® to Sustenna® in Patients With Schizophrenia
Verified December 2013 by Seoul National University Hospital
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
First received: September 27, 2012
Last updated: December 5, 2013
Last verified: December 2013
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||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
Primary Outcome Measures:
- Subjective Well-being Under Neuroleptic Treatment (SWN) [ Time Frame: Change from Baseline in SWN score at 108 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Korean Drug Attitude Inventory-10 [ Time Frame: Change from Baseline in score at 108 weeks ] [ Designated as safety issue: No ]
- Positive and Negative Syndrome Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
- Clinical Global Impression-Severity, Improvement [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
- Personal and Social Performance Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
- Symptom Check List-90-Revised [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: No ]
- Drug-Induced ExtraPyramidal Symptoms Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
- Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
- Visual Analog Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ] [ Designated as safety issue: Yes ]
injection site pain
- ECG [ Time Frame: 8, 24, 48, 72, 108 week ] [ Designated as safety issue: Yes ]
- blood pressure [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]
- Body weight [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]
- waist circumference [ Time Frame: 0,4,8,16,24,48,72,108 week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Consta Sustenna switching
The patients group who switched to paliperidone palmitate from risperidone long acting injection
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698216
|Seoul National University Hospital
|Seoul, Korea, Republic of |
|Contact: Hyun Jeong Lee, MD email@example.com |
|Principal Investigator: Yong Min Ahn, MD |
Seoul National University Hospital
||Yong Min Ahn, MD
||Seoul National University Hospital
No publications provided
||Yong Min Ahn, professor, Seoul National University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 27, 2012
||December 5, 2013
||South Korea: Korea Food and Drug Administration (KFDA)
Keywords provided by Seoul National University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents