Ravindran Research Lab - Biomarkers

Ravindran Research Lab

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Clinical Trials

Esketamine Maintenance (Study Closed)

Diagnosis: MDD

Study: Intranasal esketamine in treatment resistant depression (open-label, long-term, extension)

This is a multicenter extension study designed to assess the long-term safety, tolerability, and efficacy of intranasal esketamine in subjects with Treatment Resistant Depression who have previously participated in clinical trials of the treatment.

Inclusion:

18-64 years old during enrollment in previous study
Completion of the induction and follow up and/or optimization/maintenance phases of the two previous studies
Stable as evaluated by physical examination, vital signs, ECG, and lab assessments
Not of childbearing potential or of childbearing potential but using highly effective contraceptive methods

Exclusion:

Presence of neurodegenerative disorder or cognitive impairment
Suicidal behaviour since last study visit
Significant uncontrolled hypertension
Use of drugs of abuse
Pregnant, breastfeeding, or planning to become pregnant during study or within 6 months of last dose
Treatment with stimulants / MAOIs