OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder
Recruiting in Palo Alto (17 mi)
+62 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alkermes, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Is OLZ/SAM safe for humans?
OLZ/SAM, a combination of olanzapine and samidorphan, has been studied for its safety in humans, particularly for schizophrenia and bipolar I disorder. Research shows it aims to reduce weight gain associated with olanzapine while maintaining its effectiveness, and long-term studies have assessed its safety and tolerability over a year.
12345Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it seems you can continue if you are currently treated with olanzapine. If you are on another antipsychotic, you may need to switch if it hasn't been effective.
What data supports the effectiveness of the drug OLZ/SAM for treating schizophrenia or bipolar disorder?
Research shows that OLZ/SAM combines the effectiveness of olanzapine, a strong antipsychotic, with samidorphan to reduce weight gain, a common side effect of olanzapine, making it a promising option for treating schizophrenia and bipolar I disorder.
12345Eligibility Criteria
This trial is for young people aged 10-17 with bipolar I disorder or schizophrenia. They must be diagnosed by DSM-5 criteria, have family support, and can't be a danger to themselves or others. Participants should either be on olanzapine already or not responding well to other antipsychotics.Inclusion Criteria
I am a teenager diagnosed with schizophrenia or bipolar I disorder.
Exclusion Criteria
I have received a long-acting injectable antipsychotic within the last 3 injection cycles.
I have been diagnosed with depression or another mental health condition.
I have had a severe head injury, seizure, or major neurological issue in the last year.
My BMI is either above the 98th percentile or below the 5th percentile.
I have been diagnosed with diabetes or prediabetes.
Participant Groups
The study compares the effect of OLZ/SAM versus olanzapine alone on BMI Z-score in youth with schizophrenia or bipolar I disorder. It aims to see if OLZ/SAM leads to less weight gain than olanzapine, which is known for causing weight increase.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 OLZ/SAMExperimental Treatment1 Intervention
Fixed dose combination of olanzapine and samidorphan
Group II: Group 2 OlanzapineActive Control1 Intervention
Fixed dose of olanzapine
OLZ/SAM is already approved in United States for the following indications:
🇺🇸 Approved in United States as Lybalvi for:
- Schizophrenia
- Bipolar I disorder
- Acute treatment of manic or mixed episodes as monotherapy or adjunctively to lithium or valproate
- Maintenance monotherapy
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Alkermes Investigational SiteOrlando, FL
Alkermes Investigator SiteUpland, CA
Alkermes Investigator SiteChicago, IL
Alkermes Investigator SiteWest Chester, OH
More Trial Locations
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Who is running the clinical trial?
Alkermes, Inc.Lead Sponsor
References
Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study. [2022]Combination olanzapine and samidorphan (OLZ/SAM), in development for schizophrenia and bipolar I disorder, is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. OLZ/SAM safety, tolerability, and efficacy from a 52-week open-label extension study in patients with schizophrenia are reported.
A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: Results from the ENLIGHTEN-2 long-term extension. [2022]A combination of olanzapine and samidorphan (OLZ/SAM) is in development for the treatment of patients with schizophrenia or bipolar I disorder and is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. This 52-week open-label extension (NCT02873208; ENLIGHTEN-2-EXT) assessed the long-term safety and tolerability of OLZ/SAM in patients with schizophrenia.
Olanzapine and samidorphan combination treatment: A systematic review. [2022]The overarching aim of this review is to synthesize the efficacy, tolerability, and weight-mitigation effects of the olanzapine/samidorphan (OLZ/SAM) combination treatment in adults with schizophrenia and bipolar disorder-I.
Olanzapine-samidorphan combination tablets for the treatment of schizophrenia and bipolar I disorder - what is it, and will it be used? [2022]Although olanzapine remains one of the most efficacious antipsychotic medications for the treatment of schizophrenia, there are significant tolerability concerns related to its weight and metabolic profile. Olanzapine-samidorphan combination tablets (OLZ/SAM), branded as Lybalvi, is a newly FDA approved formulation aimed at attenuating antipsychotic induced weight gain via modulation of the endogenous opioid system with samidorphan, while retaining the robust antipsychotic efficacy of olanzapine.
Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder. [2023]To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).