Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT02431806
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female outpatients;12-17 years of age
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
* Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
* Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
* Reliable caregiver
* Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant
Key Psychiatric Exclusion Criteria:
* DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
* Mental retardation or amnestic or other cognitive disorders
* Significant suicide risk:
* Suicide attempt within the past year OR
* Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))
Key Treatment-Related Exclusion Criteria:
* Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
* Use of prohibited concomitant medication that cannot be discontinued
Other Key Medical Exclusion Criteria:
* Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
* Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2X the upper limit of normal (ULN)
* Clinically significant cardiovascular disorders
* Seizure disorder or risk of seizure
* Drug or alcohol abuse or dependence (within the past year)
* Positive urine drug screen or blood alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02431806
Study Brief:
Protocol Section:
NCT02431806