Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Alkermes, Inc.
Study ID
NCT05303064
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • OLZ/SAM — DRUG
    OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.
  • Olanzapine — DRUG
    The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day

Study Details

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Key Dates

Start date
Jun 30, 2022
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 OLZ/SAM
    Fixed dose combination of olanzapine and samidorphan
  • Active Comparator: Group 2 Olanzapine
    Fixed dose of olanzapine

Primary Outcome Measure

Change from baseline in body mass index (BMI) Zscore at week 12 [ Time Frame: 12 weeks ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Alkermes Investigator SiteDothanAlabama36303-
Alkermes Investigator SiteLittle RockArkansas72204-
Alkermes Investigator SiteEncinoCalifornia91316-
Alkermes Investigator SiteStanfordCalifornia94305-
Alkermes Investigator SiteUplandCalifornia91786-
Alkermes Investigator SiteColorado SpringsColorado80910-
Alkermes Investigator SiteDenverColorado80202-
Alkermes Investigator SiteHartfordConnecticut06106-
Alkermes Investigator SiteWashington D.C.District of Columbia20010-
Alkermes Investigator SiteMiamiFlorida33155-
Alkermes Investigator SiteMiami LakesFlorida33016-
Alkermes Investigator SiteDecaturGeorgia30030-
Alkermes Investigator SiteChicagoIllinois60611-
Alkermes Investigator SiteIndianapolisIndiana46202-
Alkermes Investigator SiteSaint CharlesMissouri63304-
Alkermes Investigator SiteLincolnNebraska68526-
Alkermes Investigator SiteOmahaNebraska68198-
Alkermes Investigator SiteParamusNew Jersey07652-
Alkermes Investigator SiteNew YorkNew York10016-
Alkermes Investigational SiteKinstonNorth Carolina28504-
Alkermes Investigator SiteCincinnatiOhio45219-
Alkermes Investigator SiteWest ChesterOhio45069-
Alkermes Investigator SiteDeSotoTexas75115-
Alkermes Investigator SiteFort WorthTexas76104-
Alkermes Investigational SiteRichmondVirginia23220-
Alkermes Investigator SiteEverettWashington98201-

Find similar trials in Dothan, AL

By condition
Bipolar disorderSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Alkermes Investigator Site· Dothan, ALAlkermes Investigator Site· Little Rock, ARAlkermes Investigator Site· Encino, CAAlkermes Investigator Site· Stanford, CAAlkermes Investigator Site· Upland, CAAlkermes Investigator Site· Colorado Springs, CO

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