Phase
Condition
Affective Disorders
Depression (Major/severe)
Depression
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
Ima Clinical Research - Phoenix
Phoenix, Arizona 85012
United StatesSite Not Available
Ima Clinical Research - Phoenix
Phoenix 5308655, Arizona 5551752 85012
United StatesSite Not Available
Sanro Clinical Research Group, Llc
Bryant 4103448, Arkansas 4099753 72022
United StatesSite Not Available
Woodland International Research Group
Little Rock 4119403, Arkansas 4099753 72211
United StatesSite Not Available
Woodland Research Northwest
Rogers 4128894, Arkansas 4099753 72758
United StatesSite Not Available
Atp Clinical Research
Orange, California 92866
United StatesSite Not Available
Nrc Research Institute
Orange, California 92868
United StatesSite Not Available
Cenexel Cns - Torrance
Torrance, California 90501
United StatesSite Not Available
Calneuro Research Group, Inc.
Los Angeles 5368361, California 5332921 90025
United StatesSite Not Available
Excell Research Inc.
Oceanside 5378771, California 5332921 92056
United StatesSite Not Available
Atp Clinical Research
Orange 5379513, California 5332921 92866
United StatesSite Not Available
Nrc Research Institute
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Artemis Institute For Clinical Research - San Diego
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Cenexel Cnr - Sherman Oaks
Sherman Oaks 5395244, California 5332921 91403-2131
United StatesSite Not Available
Cenexel Cns - Torrance
Torrance 5403022, California 5332921 90501
United StatesSite Not Available
Pacific Clinical Research Management
Upland 5404915, California 5332921 91786
United StatesSite Not Available
Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596
United StatesSite Not Available
Pharmasouth Research
Coral Gables, Florida 33146
United StatesSite Not Available
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida 32256
United StatesSite Not Available
Harmony Clinical Research Inc
North Miami Beach, Florida 33162
United StatesSite Not Available
Panhandle Research and Medical Clinic
Pensacola, Florida 32502
United StatesSite Not Available
Pharmasouth Research
Coral Gables 4151871, Florida 4155751 33146
United StatesSite Not Available
Cns Clinical Research - Coral Springs
Coral Springs 4151909, Florida 4155751 33067
United StatesSite Not Available
Gulfcoast Clinical Research Center
Fort Myers 4155995, Florida 4155751 33912
United StatesSite Not Available
Neoclinical Research
Hialeah 4158476, Florida 4155751 33016
United StatesSite Not Available
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville 4160021, Florida 4155751 32256
United StatesSite Not Available
Accel Research Sites - St. Petersburg-Largo
Largo 4161580, Florida 4155751 33777
United StatesSite Not Available
Harmony Clinical Research Inc
North Miami Beach 4166233, Florida 4155751 33162
United StatesSite Not Available
Clinical Neuroscience Solutions Inc. - Orlando
Orlando 4167147, Florida 4155751 32801
United StatesSite Not Available
Combined Research Orlando Phase I-Iv
Orlando 4167147, Florida 4155751 32807
United StatesSite Not Available
Panhandle Research and Medical Clinic
Pensacola 4168228, Florida 4155751 32502
United StatesSite Not Available
Advanced Discovery Research, Llc
Atlanta 4180439, Georgia 4197000 30318
United StatesSite Not Available
DelRicht Research
Atlanta 4180439, Georgia 4197000 30329
United StatesSite Not Available
Synexus - Atlanta
Atlanta 4180439, Georgia 4197000 30328
United StatesSite Not Available
Cenexel Iresearch - Atlanta
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Psych Atlanta, Pc
Marietta 4207783, Georgia 4197000 30060
United StatesSite Not Available
Cenexel Iresearch - Savannah
Savannah 4221552, Georgia 4197000 31405
United StatesSite Not Available
Chicago Research Center Inc.
Chicago, Illinois 60634
United StatesSite Not Available
Chicago Research Center Inc.
Chicago 4887398, Illinois 4896861 60634
United StatesSite Not Available
Advanced Quality Medical Research, LLC
Orland Park 4904937, Illinois 4896861 60462
United StatesSite Not Available
Adams Clinical - Boston
Boston 4930956, Massachusetts 6254926 02116
United StatesSite Not Available
Boston Clinical Trials Llc
Boston 4930956, Massachusetts 6254926 02131
United StatesSite Not Available
Elixia MA, LLC
Springfield 4951788, Massachusetts 6254926 01103
United StatesSite Not Available
Adams Clinical - Watertown
Watertown 4954611, Massachusetts 6254926 02472
United StatesSite Not Available
Psychiatric Care and Research Center
O'Fallon 4401242, Missouri 4398678 63368
United StatesSite Not Available
Ima Clinical Research - Las Vegas
Las Vegas 5506956, Nevada 5509151 89102
United StatesSite Not Available
Redbird Research
Las Vegas 5506956, Nevada 5509151 89119
United StatesSite Not Available
Center For Emotional Fitness
Cherry Hill 4501198, New Jersey 5101760 08002
United StatesSite Not Available
Bio Behavioral Health
Toms River 4504476, New Jersey 5101760 08755
United StatesSite Not Available
Integrative Clinical Trials, Llc
Brooklyn, New York 11229
United StatesSite Not Available
Integrative Clinical Trials, Llc
Brooklyn 5110302, New York 5128638 11229
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island 5139568, New York 5128638 10314
United StatesSite Not Available
New Hope Clinical Research
Charlotte 4460243, North Carolina 4482348 28211
United StatesSite Not Available
Insight Clinical Trials Llc
Independence 5158404, Ohio 5165418 44131
United StatesSite Not Available
Lehigh Center For Clinical Research
Allentown 5178127, Pennsylvania 6254927 18103
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United StatesSite Not Available
Clinical Neuroscience Solutions, Inc.
Memphis 4641239, Tennessee 4662168 38119
United StatesSite Not Available
Delricht Research - Plano
Plano 4719457, Texas 4736286 75024
United StatesSite Not Available
Grayline Research Center
Wichita Falls 4741752, Texas 4736286 76309
United StatesSite Not Available
Core Clinical Research
Everett, Washington 98201
United StatesSite Not Available
Core Clinical Research
Everett 5793933, Washington 5815135 98201
United StatesSite Not Available

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