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COMPLETEDPHASE1

A Phase 1 Safety Study in Adults With Schizophrenia

A Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALKS 3831 in Adult Subjects With Schizophrenia

NCT02804568•Alkermes, Inc.

View on ClinicalTrials.gov

Summary

This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a body mass index (BMI) of 18.0-35.0 kg/m\^2, inclusive
•Has a primary diagnosis of schizophrenia
•Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
•Appropriate for outpatient treatment
•Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
•Willing and able to provide government-issued identification
•Is in good physical health
•Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
•Additional criteria may apply

Exclusion Criteria

•Is currently pregnant or breastfeeding
•Initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
•Poses a current suicide risk at Visits 1 or 2
•Has a history of poor or inadequate response to treatment with olanzapine
•Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
•Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
•Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
•Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
•Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
•Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
+2 more criteria

Locations (3)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Clementon, New Jersey, United States

Alkermes Investigational Site

Dayton, Ohio, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

September 22, 2016

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

ALKS 3831

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Safety Study in Adults With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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