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Completed

NCT Number: NCT03201757

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

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Key information

Conditions

Schizophrenia Bipolar I Disorder Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing and able to give informed consent/assent as per local requirements
  • Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
  • Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
  • Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
  • Additional criteria may apply

Exclusion criteria

  • Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
  • Has a positive drug screen for drugs of abuse at study entry
  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
  • Additional criteria may apply

Treatment and study plan

ALKS 3831

Drug

Olanzapine + samidorphan, daily oral dosing

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: Up to 48 months

  2. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale

    Time frame: Up to 48 months

    The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2017
Registry last updated
Sep 26, 2024

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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