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 CERC-501 Engages Key Neural Circuitry Related to the Hedonic Response

Eligibility Criteria
  • Age between 21 and 65 years of age
  • Must meet DSM-IV TR diagnostic criteria for: Major Depressive Disorder, Bipolar I or II Depressed, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, or Post Traumatic Stress Disorder
  • Snaith-Hamilton Pleasure Scale (SHAPS) score ≥ 20
  • Reliable and willing to be available for the duration of the study
  • Willing and able to give written informed consent to participate
  • Able to understand and comply with instructions
  • If female of childbearing potential, must agree to use dual methods of contraception and be willing and able to continue contraception for 6 weeks after the last dose of study drug. Females using oral contraception must have started using it at least 2 months prior to the Baseline Visit
  • If male of childbearing potential, must have undergone surgical sterilization (such as a vasectomy) or agree to use a condom used with a spermicide during participation in the study and for 1 month after the last dose of study drug
Exclusion Criteria
  • Expected to require any hospitalization during the course of the study
  • Current/history of a psychotic disorder, current manic or mixed episode, autism spectrum disorders, mental retardation
  • Met DSMIV-TR criteria for substance abuse within the last 3 months or substance dependence within the last 6 months, excluding caffeine and/or nicotine 
  • History of unstable or untreated serious medical condition based on physician evaluation, medical history, and screening laboratory testing
  • Active suicidal intent or plan, or history of attempt within the past 3 months based on physician evaluation and Columbia Suicide Severity Rating Scale (C-SSRS)
  • Use of any antidepressant, antipsychotic, anxiolytic, anticonvulsant, mood stabilizing, muscle relaxant, centrally acting antihistaminergic, stimulant or insomnia medications (See Appendix 2) within 5 half-lives of baseline or at any time during after baseline
  • Use of any medication that is primarily metabolized by Cytochrome P450 2C8 within 14 days of baseline or at any time during the study. This includes: Cerivastatin, Paclitaxel, Repaglinide, Sorafenib, Rosiglitazone, Trimethoprim, Amodiaquine, Morphine, Amiodarone, Cabazitaxel, Carbemazepine, Chloroquine, Ibuprofen, Teprostinil, Torsemide.
  • Any contraindications to the magnetic resonance imaging procedures
  • Positive urine drug screen at Screening Visit
  • Use of any investigational medication within 3 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
  • Known hypersensitivity to CERC-501
  • History of severe allergies or multiple adverse drug reactions 
  • History of gastric disease (including peptic ulcer disease, gastritis, upper GI bleeding, or any GI precancerous condition), current clinically evident gastrointestinal complaints.
  • Current use of a proton pump inhibitor or histamine 2 blocker, or a history of chronic NSAID use
  • History of use of Salvia divinorum or use of Salvia divinorum at any time during the study
  • Any other condition that in the opinion of the investigator would preclude participation in the study
  • Any smoking of cigarettes or use of other nicotine containing products within the last month or at any time during the study 
  • Pregnant or lactating
State
Connecticut

We hope that this research study will prove that a type of drug, which we know blocks kappa opioid receptors (KOR), may help people with mood and/or anxiety disorders who have difficulty enjoying life’s pleasures. This study is a pilot or proof of concept study, which means that Dr. Sanacora and his study team ask a carefully chosen group of patients to be part of the research, and study their reaction and experience with this drug (CERC-501). We are looking for non-smokers, aged 21 to 65, who have no history of gastric disease.

Innovative Technology: Telehealth, Tablets, & Other Technologies

Patrick McGrath, PhD
Director, Alexian Brothers Center for Anxiety and Obsessive Compulsive Disorders
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois

Dr. McGrath discusses what patients need to know about telehealth technologies for treating anxiety, depression, OCD, and PTSD, including privacy and security concerns.

Learn more about telemental health