Switching From Consta® to Sustenna® in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01698216
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : December 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Consta Sustenna switching
The patients group who switched to paliperidone palmitate from risperidone long acting injection

Primary Outcome Measures :
  1. Subjective Well-being Under Neuroleptic Treatment (SWN) [ Time Frame: Change from Baseline in SWN score at 108 weeks ]

Secondary Outcome Measures :
  1. Korean Drug Attitude Inventory-10 [ Time Frame: Change from Baseline in score at 108 weeks ]
  2. Positive and Negative Syndrome Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  3. Clinical Global Impression-Severity, Improvement [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  4. Personal and Social Performance Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  5. Symptom Check List-90-Revised [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  6. Drug-Induced ExtraPyramidal Symptoms Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  7. Liverpool University Neuroleptic Side Effect Rating Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
  8. Visual Analog Scale [ Time Frame: 0,4,8,16,24,36,48,60,72,84,96,108 week ]
    injection site pain

  9. ECG [ Time Frame: 8, 24, 48, 72, 108 week ]

  10. blood pressure [ Time Frame: 0,4,8,16,24,48,72,108 week ]
  11. Body weight [ Time Frame: 0,4,8,16,24,48,72,108 week ]
  12. waist circumference [ Time Frame: 0,4,8,16,24,48,72,108 week ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01698216

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Yong Min Ahn, MD Seoul National University Hospital

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital Identifier: NCT01698216     History of Changes
Other Study ID Numbers: Consta_Sustenna
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Yong Min Ahn, Seoul National University Hospital:
subjective well-being

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists