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Effects of a nutritional supplement on weight gain after initiation of atypical antipsychotic medication in Early Psychosis patients.

Effects of a nutritional supplement on weight gain after initiation of atypical antipsychotic medication in Early Psychosis patients.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000421235
Enrollment
12
Registered
2009-06-09
Start date
2009-07-31
Completion date
Unknown
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

To see if using a nutritional supplement while starting atypical antipsychotic medications can reduce the risk of weight gain for a target group of young people aged 18-25years with Early Psychosis

Interventions

The aim of this project is to see if daily 2g oral capsule dose of Omega 3 supplement will improve the participants ability to minimise any possible weight gain that may occur when taking antipsychotic medication. The oral capsules will be taken once daily when the participants take there medically prescribed medication. To meet the 2g dose amount participants are required to take 4 oral capsule daily (at one time) as each capsule only contains 500mg of active ingredient. We are proposing th

The aim of this project is to see if daily 2g oral capsule dose of Omega 3 supplement will improve the participants ability to minimise any possible weight gain that may occur when taking antipsychotic medication. The oral capsules will be taken once daily when the participants take there medically prescribed medication. To meet the 2g dose amount participants are required to take 4 oral capsule daily (at one time) as each capsule only contains 500mg of active ingredient. We are proposing that the use of this dose Omega 3 will reduce the participants appetite and help with any possible rapid weight gain. Currently this is a new field of research and no one has tested this idea with young people who are taking antipsychotic medications for the first time. The evidence does show that many young people who start antipsychotic medications gain weight and then stop taking the medication, placing them at greater risk of getting sick again. Weight gain on antipsychotic medications is usually the most rapid during the start of treatment and in the first few weeks of starting medication. This study aims to test if using a product that is widely available with little known side effects can assist with minimising any possible weight gain that may occur on antipsychotic medications. The nutritional supplement has been widely researched in other areas of health and has been shown to improve mood. No known side effects of the nutritional supplemnt has been documented. The nutritional supplement is widely available in stores and without prescription. Each person will be asked to participate for 14 weeks in total. The first group (participants are randomly assigned to either group 1 or 2) will start on the active ingredient for 6 weeks then go onto the placebo for 8 weeks (allowing a 2 week wash out period post active ingredient). The second group will start on the placebo for 8 weeks (which is 6 weeks on placebo and then 2 weeks wash out ahead of starting the active tablets - just for consistency in the length of the trial (total 14 weeks for both groups) and then start the active ingredients for the remaining 6 weeks. Every two weeks either the nutritional supplement or the placebo will be provided by the treating doctor.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

Are accepted in to the Early Psychosis service at Princess Alexandra Hospital, Division of Mental Health. Are aged between 18 and 25 years. Have a family member/ carer/ significant other who is able to participate in the study to provide a history of food behaviours and changes... Have not been on any antipsychotic medication for greater than 4 weeks. Not currently underweight (less than 18 body mass index (BMI))

Exclusion criteria

Outside nominated age range No family member/ significant other who can participate in diet history Underweight (less than 18 BMI) Established on antipsychotic medication Not able to understand written consent form Already taking fish oil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026