Phase
Condition
Depression
Mood Disorders
Affective Disorders
Treatment
Azetukalner
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant successfully completed the treatment period of an antecedent azetukalnerPhase 3 study in MDD.
Participant provides written informed consent to participate in the study, is ableto understand the procedures and study requirements, and agrees to abide by them.
Participant is willing to comply with the contraception requirements.
Male participants must agree not to donate sperm until 3 months after the last doseof study drug. Female participants must agree not to donate ova until 3 months afterthe last dose of study drug.
Exclusion
Exclusion Criteria:
Participant met any of the withdrawal criteria, or discontinued study drug early, orwas terminated early from an antecedent study.
Participant had any protocol deviations in an antecedent azetukalner study that, inthe opinion of the investigator, would preclude participation in this study.
Participant is unable to comply with study procedures or is inappropriate for thestudy, as judged by the investigator.
Participant has any medical condition, personal circumstance, or ongoing AE (from anantecedent study) that, in the opinion of the investigator, exposes the participantto unacceptable risk by participating in the study or prevents adherence to theprotocol.
Female participant who is pregnant, breastfeeding, or planning to become pregnantwithin 3 months after the last dose of study drug.
Participant is planning to enter a clinical study with a different investigationaldrug or planning to use any experimental device for treatment of any medicalcondition during the study or within 28 days after completion of this study.
Participant is judged to have a significant risk for self-harm or suicidal behavioror is considered to be an imminent danger to themself or others, as determined bythe C-SSRS or in the opinion of the investigator.
Study Design
Connect with a study center
Chicago Research Center Inc.
Chicago, Illinois 60634
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
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