Who is eligible for research?
For most studies, men and women between 18 and 65 years of age who meet criteria for major depression and are free from recent drug and/or alcohol abuse are potentially eligible.
Potential subjects will be screened by phone to rule out any obvious exclusion criteria. Those who may be eligible for a study will be invited to our clinic for a comprehensive evaluation free of charge.
For more information about our clinic and current research studies, please call Jane Wanyiri at 203-764-9131.
Gerard Sanacora, M.D., Ph.D.
1. 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. Clinicaltrials.gov—NCT02422186: CLOSED TO RECRUITMENT
2. 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. Clinicaltrials.gov—NCT02497287: CLOSED TO RECRUITMENT
3. RAPID Ketamine: HIC#1406014074: Double-blind, placebo controlled Trial of Ketamine Therapy in Treatment-Resistant Depression. 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. Clinicaltrials.gov—NCT01920555: COMPLETED
4. FAST: 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. This phase 2A study is a double-blind, placebo-controlled, randomized, parallel-group, 6-site, trial of 8 weeks of daily dosing with 10mg of LY2456302 that is intended to test whether we can establish proof-of-concept that kappa opioid receptor (KOR) antagonists engage neural circuits involved in mediating the reward response. Clinicaltrials.gov-NCT02218736
Samuel Wilkinson, M.D.
1. HIC#1404013837: Evaluating the Feasibility and Efficacy of Computerized Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Electroconvulsive Therapy. ECT is the gold-standard for treatment-resistant depression. However, relapse rates can approach 90% within the 6 months following ECT; even with monthly ECT maintenance or medication therapy, relapse rates still remain unacceptably high (~50%). This study explores the possibility of using CBT principles to prevent relapse following a course of ECT in treatment-resistant depression patients. Clinicaltrials.gov—NCT02176473
2. 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. Clinicaltrials.gov—NCT02289248