trial

Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

NCTId NCT03187769
as of 2026-07-01
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at a glance
Phase 3 · Completed
Enrollment 426 (actual)
Sponsored by Alkermes, Inc.
Primary completion 2021-12-01
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
426 (actual)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Quadruple
Start
2017-06-08
Primary completion
2021-12-01
Eligibility
ALL · 16 Years · 40 Years

Interventions & indications

Drugs
ALKS 3831Olanzapine

Sponsors

Alkermes, Inc.Lead Sponsor

Investigators

1
Alkermes Medical Director, MDStudy Director

Sites

57 total
Little Rock, United StatesRogers, United StatesGarden Grove, United StatesSan Diego, United StatesStanford, United StatesJacksonville, United StatesNorth Miami, United StatesAtlanta, United StatesAtlanta, United StatesAugusta, United StatesChicago, United StatesWinfield, United States

Linked catalysts

1
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who H — primary completion2021-12-01

Facts & assertions

4 sourced
Enrollment
426
Phase
PHASE3
Primary Completion Date
2021-12-01
Status
COMPLETED
relationships
The graph out of here
drug
ALKS 3831
drug
Olanzapine
drug
lead_sponsor
Alkermes, Inc.
company
indication
Schizophreniform Disorders
indication
Bipolar I Disorder
indication
Psychotic Disorders
indication
investigator
Alkermes Medical Director, MD
person