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Trial registered on ANZCTR


Registration number
ACTRN12612001001886
Ethics application status
Approved
Date submitted
14/09/2012
Date registered
18/09/2012
Date last updated
17/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, open label, Phase IV multicentre efficacy and safety investigation of Paliperidone Palmitate long-acting injection in elderly people with schizophrenia.
Scientific title
A prospective, open label, Phase IV multicentre efficacy and safety investigation of Paliperidone Palmitate long-acting injection in elderly people with schizophrenia.
Secondary ID [1] 280931 0
nil
Universal Trial Number (UTN)
U1111-1133-0559
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 287023 0
Condition category
Condition code
Mental Health 287352 287352 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study designed to measure the efficacy, safety and tolerability of Paliperidone Palmitate in an elderly cohort that meet DSM-IV criteria for schizophrenia. Paliperidone palmitate is a long acting injectable antipsychotic that is administered monthly and participants will complete research procedures for a 28 week period after screening has been completed. In this study all participants that meet inclusion criteria and satisfy the screening procedure will be included. Dosage information and site of administration will be collected, but no dosage range restrictions will apply. The decision to commence treatment with Paliperidone Palmitate does not form a study procedure.
Intervention code [1] 285365 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287621 0
The change in score on the Positive and Negative Syndrome Scale (PANSS) from baseline to week 28 (6 months) in an elderly cohort with schizophrenia.

The PANSS is a widely used 30 item, 7 point rating scale used in the assessment of schizophrenia symptoms combining modified items from the Brief Psychiatric Rating Scale and the Psychopathology Rating Scale. The scale provides a definition of a symptom, and once its presence is determined, the severity. Seven items relate to positive symptoms and seven to negative symptoms with the remainder relating to general psychopathology.
Timepoint [1] 287621 0
28 weeks
Secondary outcome [1] 298545 0
Calgary Depression Scale (CDS)

The CDS is a nine item depression screen for people with schizophrenia with a four point scale to indicate severity of the symptoms. It is designed to be administered to persons with schizophrenia and has been shown to be independent of the positive and negative symptoms of schizophrenia and extrapyramidal symptoms. It has been shown to be sensitive to change in this population
Timepoint [1] 298545 0
28 weeks
Secondary outcome [2] 298546 0
Mini Mental Status Examination (MMSE)

The MMSE is a rapid 30 point questionnaire used to screen for dementia and cognitive impairment. Administration can be completed within 10 minutes. It assesses cognition over a number of domains including memory and orientation. Its use is ubiquitous in cognitive assessment in the aged.
Timepoint [2] 298546 0
28 weeks
Secondary outcome [3] 298547 0
Abnormal Involuntary Movement Scale

The AIMS is a 12 item tool that measures disordered movement associated with antipsychotics. This includes tardive dystonia and Akathisia and other motor disturbances that are related to the disease. Scoring consists of rating the severity of the movements over a 5 point scale and is commonly administered in a population with schizophrenia.
Timepoint [3] 298547 0
28 weeks
Secondary outcome [4] 298548 0
Barnes Akathisia Rating Scale (BARS)

The BARS is a measure of motor restlessness (akathisia) and is assessed over four items and is predominantly involved in the assessment of drug related akathisia as seen as a side effect of antipsychotics. It has an objective measure where the movement disorder is observed, and a subjective measure where the patient's awareness and distress in response to the movement is assessed.
Timepoint [4] 298548 0
28 weeks
Secondary outcome [5] 298549 0
Simpson-Angus Scale for the Assessment of Extrapyramidal Side Effects

The SAS is a 10 item instrument that can be completed within 10 minutes to measure drug induced Parkinsonism. The items are measured on a 5 point scale with seven items measuring rigidity and the remaining items measuring tremor and pooling of saliva in the mouth.
Timepoint [5] 298549 0
28 weeks
Secondary outcome [6] 298551 0
WHO Quality of Life BREF (WHO-QOL-BREF)

The WHO-QOL-BREF is a 26 item questionnaire of quality of life that was developed to measure QOL in the context of an individual's culture and value systems as well as their personal values and concerns. The scale assesses across physical and mental health social situations and the environment.
Timepoint [6] 298551 0
28 weeks
Secondary outcome [7] 298552 0
Blood Pathology

- Fasting glucose;
- Fasting cholesterol;
- U&E's including eGFR;
- FBE;
- Prolactin;
- Cholesterol (HDL and LDL);
- Triglycerides.
Timepoint [7] 298552 0
28 weeks

Eligibility
Key inclusion criteria
Aged 65 – 80 years of age

DSM-IV diagnosis of schizophrenia

eGFR of => 50 ml/min

Capacity to consent as assessed by the treating psychiatrist.

A clinical decision has been made to treat the patient with Paliperidone Palmitate by the treating psychiatrist. (Concomitant use of other psychotropic drugs is permitted as per the clinical judgement of the treating psychiatrist.)
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incapacity or refusal to consent to study participation.

Insufficient English to complete the study procedures

Known hypersensitivity to risperidone or paliperidone

History of CVA

History of seizures

Recent (past 6 months) history of substance abuse that is judged to be clinically significant

Clinical diagnosis of dementia

Clinical diagnosis of Parkinson’s disease

Where, in the opinion of the treating psychiatrist, participation would be prejudicial to the participant’s physical or mental health.

Moderate - severe renal impairment (cut off eGFR of < 50 ml/min) as measured prior to study commencement.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2012
Actual
11/06/2013
Date of last participant enrolment
Anticipated
Actual
11/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285712 0
Commercial sector/Industry
Name [1] 285712 0
Janssen-Cilag Pty Ltd
Country [1] 285712 0
Australia
Primary sponsor type
Hospital
Name
Aged Psychiatry Service, Caulfield Hospital
Address
Aged Psychiatry Service,
Caulfield Hospital,
Alfred Health,
260 Kooyong Road,
Caulfield,
Vic,
3162
Country
Australia
Secondary sponsor category [1] 284542 0
None
Name [1] 284542 0
Address [1] 284542 0
Country [1] 284542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287720 0
Alfred Health Human Research and Ethics Committee
Ethics committee address [1] 287720 0
Research and Ethics Office
The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria 3004,
Ethics committee country [1] 287720 0
Australia
Date submitted for ethics approval [1] 287720 0
01/08/2012
Approval date [1] 287720 0
02/10/2012
Ethics approval number [1] 287720 0
HREC/12/Alfred/44 (Local Reference: Project 279/12)

Summary
Brief summary
Paliperidone palmitate (Invega Sustenna) is a recently approved long acting injectable antipsychotic medication to treat schizophrenia that is only required to be administered monthly, unlike others which require daily or fortnightly administration. It is useful in people where previous drugs have been ineffective, or where taking oral medications has been a problem as doses are more closely monitored and clinical staff will know quickly when doses are missed.

For Invega Sustenna to be approved for use in adults by the government, a number of studies were conducted in adults aged 18-65 that showed it was effective, and that its benefits outweighed any side effects. It is assumed that this information will be applicable to an elderly population with schizophrenia, but this has not been directly studied. In this study we will explore how effective the medication is as well as its safety and how well tolerated Invega Sustenna is in an elderly population with schizophrenia where a clinical decision has been made to commence treatment using the drug.

The study will add a number of measures to standard care to measure whether the symptoms of schizophrenia are changed and also whether there are any significant side effects. After ensuring that all participants meet our inclusion and exclusion criteria, we will conduct frequent assessments of patients over a 6 month period. This information will be used to treat any side effects as soon as they occur and to build up a profile of the side effects that could be expected to be seen in the elderly and add to the knowledge about the side effects of this medication in an elderly population.

The results will be published in a medical journal and provided to the drug company so that they can update their product information so that any side effects can be better dealt with.
Trial website
n/a
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34501 0
A/Prof Stephen Macfarlane
Address 34501 0
Aged Psychiatry Service, Caulfield Hospital, 260 Kooyong Road, Caulfield, Victoria, 3162
Country 34501 0
Australia
Phone 34501 0
+61 (0)3 9076 6000
Fax 34501 0
Email 34501 0
[email protected]
Contact person for public queries
Name 17748 0
A/Prof Stephen Macfarlane
Address 17748 0
Aged Psychiatry Service,
Caulfield Hospital,
260 Kooyong Road,
Caulfield,
Victoria,
3162
Country 17748 0
Australia
Phone 17748 0
+61 (0)3 9076 6000
Fax 17748 0
+61 (0)3 9076 6180
Email 17748 0
[email protected]
Contact person for scientific queries
Name 8676 0
A/Prof Stephen Macfarlane
Address 8676 0
Aged Psychiatry Service,
Caulfield Hospital,
260 Kooyong Road,
Caulfield,
Victoria,
3162
Country 8676 0
Australia
Phone 8676 0
+61 (0)3 9076 6000
Fax 8676 0
+61 (0)3 9076 6180
Email 8676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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