Clinical trial NCT02459236 (phase 2, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: cerc-301, placebo
SMILES: CC1=CC=C(COC(=O)N2CC[C@H](CNC3=NC=CC=N3)[C@H](F)C2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of MDD recurrent without psychotic features according to DSM-IV-TR criteria
             with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I
             Disorders Clinical Trials Version (SCID-CT).

          2. Lifetime history of ≥2 major depressive episodes, for which at least one required
             treatment with SSRI or SNRI antidepressants.

          3. History during the current major depressive episode of failure to achieve a
             satisfactory response (e.g., less than 50% improvement of depression symptoms) to ≤3
             treatment courses of a therapeutic dose of an antidepressant therapy of at least 8
             weeks duration during the current episode, according to the Massachusetts General
             Hospital Antidepressant Treatment Response Questionnaire.

        Exclusion Criteria:

          1. Duration of current depression episode ≥2 years or diagnosis of Persistent Depressive
             Disorder (DSM-V) or Dysthymic Disorder (DSM-IV)

          2. Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine,
             memantine) within 30 days of screening and throughout the study.

          3. History of use of an NMDA-receptor modulator for the treatment of MDD.

          4. Use of bupropion, tricyclic antidepressants, antipsychotics, stimulants, or lithium
             within 8 weeks prior to screening

          5. Initiation of psychotherapy or a change in intensity of psychotherapy or other
             non-drug therapies (e.g., hypnosis, acupuncture) within 8 weeks prior to screening.

          6. Electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve
             stimulation during the current depressive episode.

          7. Excessive alcohol use, which is defined by the Centers for Disease Control as >1 drink
             per day for women and >2 drinks per day for men.

          8. Current diagnosis of a Substance Use (including alcohol) Disorder (Abuse or
             Dependence, as defined by DSM-IV/V), with the exception of nicotine dependence, at
             screening or within 6 months prior to screening.

          9. Active, comorbid disease that might limit the ability of the subject to participate in
             the study as determined by the Investigator (i.e., poorly controlled diabetes
             mellitus, congestive heart failure, etc.).

         10. Current neurologic or neuropsychiatric disorder which could interfere with the ability
             to diagnose or assess MDD or which could cause or contribute to depressive
             symptomatology (e.g., Alzheimer's disease, Parkinson's diseases, chronic pain
             syndromes, including fibromyalgia, substance use disorder, post-partum depression).

         11. Lifetime history of the following disorders: Bipolar I, II, or Not Otherwise Specified
             (NOS) mood disorders, eating disorders , schizophrenia and other psychotic disorders,
             sleep disorders , significant cognitive disorders, dissociative disorders, impulse
             control disorders, and borderline, antisocial, paranoid, schizoid, schizotypal, or
             histrionic personality disorders.

         12. Subjects with suicidal behavior within 6 months prior to screening as measured by the
             Columbia-Suicide Severity Rating Scale (C-SSRS) "Baseline/Screening" version.

         13. Elevated seated blood pressure at screening and prior to randomization

         14. Lifetime history of stroke or congestive heart failure, atrial fibrillation or
             coronary artery disease.

         15. Clinically significant current liver disease or liver enzyme (GGT, ALT, AST, total
             bilirubin) elevations at screening above 2 × the ULN.

         16. Clinically significant renal impairment defined as estimated creatinine clearance
             [CrCl] <50 mL/min at screening measured using Cockcroft-Gault formula.

         17. Fasting serum glucose >140 mg/dL.

         18. Subjects who, in the opinion of the Investigator, are not appropriate for a 21-day
             placebo-controlled study due to risk of significant threat to self or others during
             screening or study conduct.

         19. Previous participation in an investigational study using CERC-301.

         20. Participation in an investigational drug or device study within the 6 months prior to
             screening.