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Yale Depression Research Program posts open case studies

May 12, 2016

The Yale Depression Research Program (YDRP), under the direction of Gerard Sanacora, MD, PhD, professor of psychiatry, seeks participants for six open case studies.

For information about the studies, call YDRP at 203-764-9131, or visit the program's website.

Principal Investigator: Gerard Sanacora, MD, PhD

RAPID Ketamine: HIC#1406014074: Double-blind, placebo controlled Trial of Ketamine Therapy in Treatment-Resistant Depression. Ages 18-70.

Summary: This research study is designed to look at the whether single doses (0.1mg/kg, 0.2mg/kg, 0.5mg/kg and 1.0mg/kg) of ketamine are superior to active placebo (0.045mg/kg midazolam) therapy in the acute treatment of patients with TRD within 72 hours when added to ongoing, stable and adequate antidepressant therapy.—NCT01920555

HIC#1404013717: A Phase 2a Study to Evaluate the Kappa Opioid Receptor as a Target for the Treatment of Mood and Anxiety Spectrum Disorders by Evaluation of Whether LY2456302 Engages Key Neural Circuitry Related to the Hedonic Response. Ages 21-65.

Summary: The primary objective is to establish proof-of-concept for Kappa Opioid Receptor antagonism by evaluating the impact of LY2456302 10mg relative to Placebo on reward-related neural circuitry in terms of ventral striatal fMRI activation during anticipation of reward during the Monetary Incentive Delay (MID) Task.—NCT02218736

HIC#1510016731: A Randomized, Double-Blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects with Treatment-resistant Depression. Ages 65 and up.

The primary objective of this study is to evaluate the efficacy of switching elderly subjects with Treatment-resistant depression from a prior antidepressant treatment (to which they have not responded) to flexibly-dosed intranasal esketamine plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms, as assessed by the change from baseline in the MADRS total score from Day 1 (pre-randomization) to the end of the 4-week double-blind induction phase.—NCT02422186

HIC#1601017052: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression. Ages 18 and up.

The primary objective of this study is to assess the long-term safety and tolerability of intranasal esketamine plus a newly initiated oral antidepressant in subjects with Treatment-resistant depression, with special attention to the following: 1. Potential effects on cognitive function 2. Potential treatment-emergent symptoms of cystitis and/or lower urinary tract symptoms 3. Potential withdrawal and/or rebound symptoms following cessation of intranasal esketamine treatment.—NCT02497287

Principal Investigator: Samuel Wilkinson, MD

HIC#1501015171: Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine.

Each patient receives 4 infusions of ketamine (twice weekly for two weeks); this overlays with intensive CBT (sessions twice weekly). After completing 4 ketamine infusions, patients continue with CBT for up to 8 weeks (10 total weeks). Patients also receive cognitive testing to explore the relationship between IV ketamine and cognition.—NCT02289248

Principal Investigator: Chadi Abdallah, MD

HIC#1305011972: Examining the Effects of Ketamine on Glutamate/Glutamine Cycling

This research study takes advantage of recent developments in frontal 13C Magnetic Resonance Spectroscopy (13C-MRS)-a method to measure glutamate/glutamine cycling non-invasively in vivo- to determine the effect of ketamine on glutamate neurotransmission cyclingin a group of healthy volunteers and in patients with Major Depressive Disorder.—NCT02037035

Submitted by Christopher Gardner on May 12, 2016