Clinical trial NCT02218736 (phase 2, status: completed)
Conditions: anxiety disorders (or anxiety and phobic neuroses)
ICD codes: F20.81, F21, F34.0, F34.1, F42.3, F45.0, F51.5
Drugs: cerc-501, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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