Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Participants must be medically stable, based on investigator review of medicalhistory, vital signs (including blood pressure), and clinical judgment. In cases ofany medical concern, the investigator has the option to perform local 12-leadelectrocardiogram (ECG) or local clinical laboratory testing at screening. Thisdetermination must be recorded in the participant's source documents and initialedby the investigator
Meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5)diagnostic criteria for major depressive disorder (MDD), without psychotic featuresbased upon clinical assessment and confirmed by the structured clinical interviewfor DSM-5 axis I disorders-clinical trials version (SCID-CT). Must be diagnosed withfirst depressive episode prior to age 60
Have had an inadequate response to at least 1 but no more than 2 antidepressants,administered at an adequate dose and duration started in the current episode ofdepression. The current antidepressant cannot be the first antidepressant treatmentfor the first lifetime episode of depression. An inadequate response is defined asless than (<) 50 percent (%) reduction but with some improvement (that is,improvement greater than [>] 0%) in depressive symptom severity with residualsymptoms present, and overall good tolerability, as assessed by the massachusettsgeneral hospital-antidepressant treatment response questionnaire (MGH-ATRQ). Anadequate trial is defined as an antidepressant treatment for at least 6 weeks on astable dose at or above the minimum therapeutic dose specified in the MGH-ATRQ, andthis must include the participant's current antidepressant treatment
Is receiving and tolerating well any one of the following selective serotoninreuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) fordepressive symptoms at screening, in any formulation and approved by the Food andDrug Administration (FDA): citalopram, duloxetine, escitalopram, fluvoxamine,fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine,desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic doselevel per MGH-ATRQ) for at least 6 weeks
Has a body mass index (BMI) of 18 to 40 kilograms per meter square (Kg/m^2),inclusive
Exclusion
Exclusion criteria:
Had major surgery (for example, requiring general anesthesia) within 2 weeks beforescreening, or will not have fully recovered from surgery, or has surgery plannedduring the time the participant is expected to participate in the study
Has a history of treatment-resistant MDD, defined as a lack of response to 2 or moreadequate antidepressant treatments in the current episode, as indicated by no orminimal (less than or equal to [<=] 25%) improvement in symptoms when treated withan antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks)
Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder,social anxiety disorder, or specific phobia which has been the primary focus ofpsychiatric treatment within the past 2 years. These are allowed as secondarydiagnoses if MDD is the primary focus of treatment according to the investigator
Has a history or current diagnosis of a psychotic disorder, bipolar disorder,intellectual disability, autism spectrum disorder, borderline personality disorder,or somatoform disorders
Has cognitive impairment per investigator judgment that would render the informedconsent invalid or limit the ability of the participant to comply with the studyrequirements. Participant has neurodegenerative disorder (for example, alzheimer'sdisease, vascular dementia, parkinson's disease with clinical evidence of cognitiveimpairment) or evidence of mild cognitive impairment
Study Design
Connect with a study center
Behavioral Research Specialists LLC
Glendale, California 91206
United StatesActive - Recruiting
Pacific Clinical Research Medical Group
Upland, California 91786
United StatesCompleted
Sunwise Clinical Research
Walnut Creek, California 94596
United StatesActive - Recruiting
Behavioral Research Specialists LLC
Glendale 5352423, California 5332921 91206
United StatesSite Not Available
Pacific Clinical Research Medical Group
Upland 5404915, California 5332921 91786
United StatesSite Not Available
Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596
United StatesSite Not Available
Velocity Clinical Research
Hallandale, Florida 33009
United StatesActive - Recruiting
Meridian International Research
Miami Gardens, Florida 33014
United StatesActive - Recruiting
Velocity Clinical Research
Hallandale 4157898, Florida 4155751 33009
United StatesSite Not Available
Meridian International Research
Miami Gardens 4164167, Florida 4155751 33014
United StatesSite Not Available
IMA Clinical Research PC
Chicago, Illinois 60634
United StatesActive - Recruiting
Chicago Research Center
Chicago 4887398, Illinois 4896861 60634
United StatesSite Not Available
Adams Clinical
Boston, Massachusetts 02116
United StatesActive - Recruiting
Adams Clinical
Watertown, Massachusetts 02472
United StatesActive - Recruiting
Adams Clinical
Boston 4930956, Massachusetts 6254926 02116
United StatesSite Not Available
Adams Clinical
Watertown 4954611, Massachusetts 6254926 02472
United StatesSite Not Available
Adams Clinical
New York, New York 10029
United StatesActive - Recruiting
Adams Clinical
The Bronx, New York 10461
United StatesActive - Recruiting
Adams Clinical
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Adams Clinical
The Bronx 5110266, New York 5128638 10461
United StatesSite Not Available
Adams Clinical
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Adams Clinical
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Adams Clinical
DeSoto, Texas 75115
United StatesActive - Recruiting
Adams Clinical
DeSoto 4685524, Texas 4736286 75115
United StatesSite Not Available
Inner Space Research LLC
Orem, Utah 84058
United StatesActive - Recruiting
Inner Space Research LLC
Orem 5779334, Utah 5549030 84058
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesActive - Recruiting
Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
United StatesSite Not Available

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