Status
Ongoing
Title
Safety of atypical antipsychotic use in children and adolescents: a cohort study using the QResearch database.
What is the aim of the study and why is it important?
Antipsychotic medications can be prescribed to children and young people with certain mental health issues. Some of them are serious, such as schizophrenia. Others include aggression and disruptive behaviour, intellectual disability and autism, and tics. These conditions often require long-term treatment and the drugs may be prescribed for months or years.
It is know that antipsychotics have side effects which include substantial weight gain and increased risk of type 2 diabetes. However, there is limited evidence about the safety of different types of antipsychotics in children and young people. Existing studies have mostly been short-term and focused on fairly healthy adult patients. These studies only covered a limited number of drugs, or were too small to find differences between drugs.
We shall investigate real-life use of all prescribed antipsychotics and study long-term side-effects for them. We shall include all children and young people prescribed such drugs and look specifically for unhealthy weight gain or development of diabetes associated with different antipsychotic drugs.
Chief Investigator
Yana Vinogradova
Lead Applicant Organisation Name
Sponsor
Oxford
Location of research
Oxford/Nottingham
Date on which research approved
28-Jan-2019
Project reference ID
OX7
Generic ethics approval reference
18/EM/0400
Are all data accessed are in anonymised form?
Yes
Brief summary of the dataset to be released (including any sensitive data)
GP record information about age, gender, diagnoses for mental health and other medical conditions (especially those which could lead to diabetes); weight; body mass index; antipsychotic medication; medication used to treat diabetes
Implications and Impact
The results of our study will provide more detailed information for doctors and patients about relative risks of weight gain and type 2 diabetes for all antipsychotic medications and will help them to make more informed choices. This will be particularly important for children and young people who are already overweight or at higher risk of diabetes because of other medical conditions. The information will also be used to develop best-practice guidelines.
Funding Source
Nottingham Biomedical Research Centre
Public Benefit Statement
Research Team
Yana Vinogradova, Carol Coupland; Chris Hollis; Ruth Jack; Rebecca Joseph (University of Nottingham), Julia Hippisley-Cox (University of Oxford).
Access Type
Trusted Research Environment (TRE)