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Completed

NCT Number: NCT02634346

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
  • Meets criteria for the diagnosis of schizophrenia
  • Resides in a stable living situation when not hospitalized
  • Is willing and able to provide government-issued identification
  • Additional criteria may apply

Exclusion criteria

  • Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
  • Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
  • Subject poses a current suicide risk
  • Subject has a history of treatment resistance
  • Subject has a history of poor or inadequate response to treatment with olanzapine
  • Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
  • Subject has a diagnosis of moderate or severe alcohol or drug use disorder
  • Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
  • Additional criteria may apply

Treatment and study plan

ALK3831

Drug

Daily dosing

Olanzapine

Drug

Daily dosing

Placebo

Drug

Daily dosing

Primary outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

    Time frame: 4 weeks

    This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.

Secondary outcomes

  1. Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4

    Time frame: 4 weeks

    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.

  2. Incidence of Adverse Events

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2015
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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