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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
26,292 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When might ALKS 3831 receive FDA approval?

"There is some efficacy data and numerous rounds of safety data, so ALKS 3831 received a score of 3."

Answered by AI

Could you please tell me if adolescents are able to enroll in this research project?

"Researchers are looking for study participants that are under 70 and over the age of 16."

Answered by AI

Are we still able to enroll participants for this clinical trial?

"Although this study is not looking for patients at this moment, information from clinicaltrials.gov suggests that it might in the future. The trial was first posted on 6/15/2017 and was last edited on 2/10/2022. There are presently 1320 other studies seeking patients."

Answered by AI

Does this research require specific health qualifications from participants?

"To be eligible for this study, potential participants must be between 16-70 years old, currently have a diagnosis of schizophrenia, and be willing to use contraception during the study period and for 30 days after the study. There are additional requirements that participants must meet."

Answered by AI

What is the geographic scope of this research project?

"To cut down on travel requirements for participants, this trial is being conducted at 43 sites that are near DeSoto, Brooklyn and Decatur."

Answered by AI

Who else is applying?

What state do they live in?
Other
Illinois
California
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Alkermes Investigational Site
Other

Why did patients apply to this trial?

I’ve tried other drugs that didn’t work. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived no prior treatments
I have bipolar and would like to contribute to research for bipolar treatments. I'm a current medical student so I understand how important these trials are to advance research and patient outcomes.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Would I have to change medications from the one I currently take to the one being studied?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
2017. "Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03201757.
~67 spots leftby Apr 2025
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