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Trial record 20 of 3310 for:    schizophrenia

Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate

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ClinicalTrials.gov Identifier: NCT02532842
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
The primary objective of this study is to explore hospitalization (number, length and reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants during the first 12 months of treatment with once monthly paliperidone palmitate in naturalistic clinical settings.

Condition or disease
Schizophrenia

Detailed Description:
This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected. The study will be conducted in countries within the EMEA region in which paliperidone palmitate is approved and available. The study will be considered complete with the last data collection for the last participant participating in the study.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Paliperidone Palmitate in Early Schizophrenia - A Retrospective, Non-interventional Study of Patients With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate Over a 12-Month Period
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Participants with Schizophrenia
This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected.



Primary Outcome Measures :
  1. Number of Hospitalizations [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of Treatment Patterns of paliperidone palmitate as measured by patient records [ Time Frame: 12 months ]
  2. Treatment response Based on clinical illness, symptom severity and measurements of functioning Score [ Time Frame: 12 months ]
  3. Parameters of Psychosocial Functioning based on questionnaire [ Time Frame: 12 months ]
  4. Medical Resource Utilization [ Time Frame: 12 months ]
  5. Psychiatric hospitalizations preceding the first paliperidone palmitate injection [ Time Frame: 12 months ]
  6. Number of Participants with Adverse Events [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed (<= 1 year [y] before start of PP treatment) with >= 18 y and <=29 y of age and who received PP for at least 12 months prior to study start of the study (retrospective cohort).
Criteria

Inclusion Criteria:

  • Participant must be a man or woman aged at least 18 years but not more than 29 years at the time of the first injection of paliperidone palmitate
  • Participant must have a documented diagnosis of schizophrenia according to either Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD 10) or Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM 4)
  • Participant's first psychotic episode suggestive of schizophrenia must have been clinically evident not longer than 1 year prior to the first injection of paliperidone palmitate
  • Participant must have documentation (medical records) of at least 12 months (365 +/- 31 days) continuous treatment with paliperidone palmitate administered for the first time as part of clinical practice. This documentation must have been completed in the participant's records before the initiation of the study site
  • Participant must have initiated paliperidone palmitate treatment after the launch date (ie, commercial availability) of paliperidone palmitate at his/her respective site

Exclusion Criteria:

  • Participant has either an ICD 10 or DSM 4 axis I diagnosis other than schizophrenia
  • Participant was diagnosed with alcohol or drug dependence (except for nicotine and caffeine dependence) according to either ICD 10 or DSM 4 criteria within 1 month prior to initiation of paliperidone palmitate treatment or during the 12 month documentation period
  • Participant was treated with any long acting injectable antipsychotic prior to paliperidone palmitate initiation or with a long-acting injectable antipsychotic other than paliperidone palmitate during the 12 month documentation period
  • Participant received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days prior to paliperidone palmitate initiation or during the 12 month documentation period
  • Participant participated in an interventional or a non-interventional clinical study during the 12 month documentation period

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 ClinicalTrials.gov identifier (NCT number): NCT02532842


Locations
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Croatia
Rijeka, Croatia
Split, Croatia
Zagreb, Croatia
Russian Federation
Moscow, Russian Federation
St Petersburg N/A, Russian Federation
St-Petersburg, Russian Federation
Turkey
Ankara, Turkey
Denizli, Turkey
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Clinical Trial Janssen Pharmaceutica N.V., Belgium Janssen Pharmaceutica N.V., Belgium

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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT02532842     History of Changes
Other Study ID Numbers: CR105892
R092670SCH4041 ( Other Identifier: Janssen Pharmaceutica NV )
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Schizophrenia
Paliperidone palmitate
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents