A prospective, open label, Phase IV multicentre efficacy and safety investigation of Paliperidone Palmitate long-acting injection in elderly people with schizophrenia.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612001001886

Enrollment

Registered

2012-09-18

Start date

2013-06-11

Completion date

2013-06-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 informat

Eligibility

Sex/Gender

All

Age

65 Years to 80 Years

Healthy volunteers

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.)

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.

Outcome results