Switching From Consta® to Sustenna® in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698216
• Other study ID #: Consta_Sustenna
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: December 7, 2015
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Well-being Under Neuroleptic Treatment (SWN)		Change from Baseline in SWN score at 108 weeks	No
Secondary	Korean Drug Attitude Inventory-10		Change from Baseline in score at 108 weeks	No
Secondary	Positive and Negative Syndrome Scale		0,4,8,16,24,36,48,60,72,84,96,108 week	No
Secondary	Clinical Global Impression-Severity, Improvement		0,4,8,16,24,36,48,60,72,84,96,108 week	No
Secondary	Personal and Social Performance Scale		0,4,8,16,24,36,48,60,72,84,96,108 week	No
Secondary	Symptom Check List-90-Revised		0,4,8,16,24,36,48,60,72,84,96,108 week	No
Secondary	Drug-Induced ExtraPyramidal Symptoms Scale		0,4,8,16,24,36,48,60,72,84,96,108 week	Yes
Secondary	Liverpool University Neuroleptic Side Effect Rating Scale		0,4,8,16,24,36,48,60,72,84,96,108 week	Yes
Secondary	Visual Analog Scale	injection site pain	0,4,8,16,24,36,48,60,72,84,96,108 week	Yes
Secondary	ECG	electrocardiogram	8, 24, 48, 72, 108 week	Yes
Secondary	blood pressure		0,4,8,16,24,48,72,108 week	Yes
Secondary	Body weight		0,4,8,16,24,48,72,108 week	Yes
Secondary	waist circumference		0,4,8,16,24,48,72,108 week	Yes