Nuedexta in Treatment-Resistant Major Depression

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

There is an urgent need, therefore, to identify well-tolerated, orally available compounds that target the NMDA receptor as a novel treatment approach for TRD. The current project aims to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Murrough
• Treatments: Antidepressive Agents; Dextromethorphan; Quinidine; Quinidine gluconate

Criteria

Inclusion Criteria:

• Male or female participants, 18-65 years of age;

• Current primary Axis I diagnosis of major depressive disorder according to DSM-IV-TR criteria as determined by a psychiatrist and confirmed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID);

• Current treatment-resistant depression defined by a history of inadequate response to a minimum of 2 adequate antidepressant treatment trials determined by patient history and chart review and confirmed with the Antidepressant Treatment History Form (ATHF);

• Participants must be willing to discontinue treatment with concomitant medications that are disallowed by the study protocol;

• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

• Lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, pervasive developmental disorders or mental retardation

• Diagnosis of a substance use disorder within the past 1 year ;

• Female participants who are pregnant, nursing, for may become pregnant;

• Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;

• Participants with clinically significant abnormalities of laboratories, physical examination, or ECG;

• Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure;

• Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block

• Participants with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions;

• Participants judged to be at serious suicidal risk by the PI;

• Concomitant use with quinidine, quinine, or mefloquine;

• Participants with known hypersensitivity to dextromethorphan;

• Use with an MAOI or within 14 days of stopping an MAOI;

• Concomitant use with drugs that prolong QT interval and are metabolized by CYP2D6