To Evaluate the Effect of ALKS3831 vs olanzapine in Young Adults (307)
Research type
Research Study
Full title
A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
IRAS ID
236776
Contact name
Ekwere George Umoh
Contact email
Sponsor organisation
Alkermes Inc
Eudract number
2017-000497-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 7 days
Research summary
The purpose of this phase 3 study is to compare weight gain in patients taking ALKS 3831 versus patients taking only olanzapine. This research study will look at the effects of taking olanzapine and samidorphan together, in a bi-layer tablet (both medications together in one tablet). Olanzapine and samidorphan are the active ingredients in the study drug being developed called “ALKS 3831”.
Olanzapine is an atypical antipsychotic that has been approved by a number of different countries to treat schizophrenia and bipolar disorder. A common side effect of olanzapine is that it causes weight gain. ALKS 3831 is designed to reduce some of olanzapine's weight gain. The present study will see if there is a reduction in weight gain when ALKS 3831 is given to adolescents and young adults.
The study will look at a large group of patients with schizophrenia, schizophreniform disorder, or bipolar I disorder, to see if patients taking ALKS 3831 gain less weight than patients taking olanzapine alone.Samidorphan is made from the medication named naltrexone which blocks the pain relief action of opioid drugs.
Drugs of this type do not cause addiction or physical dependence.
About 350 people will enrol in this study at many study sites in different countries.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0019
Date of REC Opinion
23 Jan 2018
REC opinion
Unfavourable Opinion