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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALK3831; Drug: Placebo; Drug: Olanzapine

• Registration Number: NCT02634346
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-18
• Primary Completion: 2017-05-25
• Study Completion: 2017-06-07
• Status Verified: 2018-05
• Results First Submitted: 2018-05-25
• Results First Submitted QC: 2018-05-25
• Last Update Submitted: 2018-05-25
• Results First Posted: 2018-06-27
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 3831	ALK3831	Administered as a coated bilayer tablet
Placebo	Placebo	Administered as a coated bilayer tablet
Olanzapine	Olanzapine	Administered as a coated bilayer tablet

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	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 Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	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.
Incidence of Adverse Events	Approximately 4 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇦 Vinnytsia, Ukraine