A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

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Alkermes

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Olanzapine
Drug: ALKS 3831

Study type

Interventional

Funder types

Industry

Identifiers

NCT02694328
ALK3831-A303

Details and patient eligibility

About

This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Enrollment

561 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
  • Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
  • Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
  • Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
  • Additional criteria may apply

Exclusion criteria

  • Subject has any of the following psychiatric conditions per DSM-5 criteria:
  • Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
  • Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
  • Drug-induced or toxic psychosis
  • Any other psychiatric condition that could interfere with participation in the study
  • Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
  • Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
  • Additional criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

561 participants in 2 patient groups

ALKS 3831
Experimental group
Description:
Administered as a coated bilayer tablet
Treatment:
Drug: ALKS 3831
Olanzapine
Active Comparator group
Description:
Administered as a coated bilayer tablet
Treatment:
Drug: Olanzapine

Trial documents
2

Trial contacts and locations

54

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Data sourced from clinicaltrials.gov

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