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Atypical Antipsychotic

ALKS 3831 for Bipolar Disorder

Phase 3
Waitlist Available
Research Sponsored by Alkermes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of ALKS 3831 in people with schizophrenia, schizophreniform disorder, or bipolar I disorder.

Eligible Conditions
  • Bipolar Disorder
  • Schizophrenia
  • Schizophreniform Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety will be measured by frequency of serious and non-serious adverse events
Other outcome measures
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Change from baseline in body weight

Side effects data

From 2022 Phase 3 trial • 426 Patients • NCT03187769
22%
Weight Increased
11%
Somnolence
8%
Alanine aminotransferase increased
6%
Headache
5%
Sedation
5%
Waist Circumference Increased
4%
Anxiety
4%
Blood creatine phosphokinase increased
4%
Fatigue
4%
Nausea
3%
Dizziness
3%
Dry mouth
3%
Increased appetite
3%
Vomiting
3%
Aspartate aminotransferase increased
2%
Back pain
1%
Schizophrenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALKS 3831
Olanzapine

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALKS 3831Experimental Treatment1 Intervention
Coated bilayer tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALKS 3831
2016
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,364 Total Patients Enrolled
Alkermes Medical DirectorStudy DirectorAlkermes, Inc.
11 Previous Clinical Trials
3,705 Total Patients Enrolled

Media Library

ALKS 3831 (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT03201757 — Phase 3
Bipolar Disorder Research Study Groups: ALKS 3831
Bipolar Disorder Clinical Trial 2023: ALKS 3831 Highlights & Side Effects. Trial Name: NCT03201757 — Phase 3
ALKS 3831 (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03201757 — Phase 3
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT03201757 — Phase 3
~66 spots leftby Jun 2025
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