Status:
COMPLETED
Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a
Lead Sponsor:
Duke University
Collaborating Sponsors:
Yale University
Baylor College of Medicine
Conditions:
ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
The available treatment for patients with mood and anxiety disorders have significant limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments for people with these...
Detailed Description
FAST-MAS addresses an important problem and critical barrier to progress in Mood and Anxiety Spectrum Disorders and if the aims of the project are achieved, FAST-MAS could shift scientific knowledge, ...
Eligibility Criteria
Inclusion
- Age between 21 and 65 years of age
- Must meet DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) 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 afterward
Exclusion
- Expected to require 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 (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) 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, Carbamazepine, Chloroquine, Ibuprofen, Trepostinil, Torsemide.
- Any contraindications to the magnetic resonance imaging procedures
- Positive urine drug screen at any time during the study
- 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 (formerly known as LY2456302)
- 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, or positive urea breath test
- Current use of a proton pump inhibitor or histamine 2 blocker, or a history of chronic NSAID (nonsteroidal anti-inflammatory drug) 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
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT02218736
Start Date
June 1 2015
End Date
December 1 2017
Last Update
January 8 2019
Active Locations (6)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
Andrew Goddard, MD
Indianapolis, Indiana, United States, 46202-l7176
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Duke University Medical Center
Durham, North Carolina, United States, 27710