Phase 2
N=20
Nuedexta in Treatment-Resistant Major Depression
Major Depressive Disorder · Treatment Resistant
Bottom Line
View on ClinicalTrials.gov: NCT01882829 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Jun 2018
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale — -13.0 change in units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dextromethorphan/quinidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- James Murrough
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale |
-13.0 | — |
| SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire Short Form |
0.1 | — |
| SECONDARY Range of Impaired Functioning Tool |
-3.7 | — |
| SECONDARY Sheehan Disability Scale |
-4.3 | — |
| SECONDARY Patient Rated Inventory of Side Effects (PRISE) |
25 | — |
| SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS) |
0.1 | — |
| SECONDARY Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) |
-5.9 | — |
| SECONDARY Clinical Global Impression (CGI) Scale |
-1.5 | — |
| SECONDARY Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) |
-4.1 | — |
| SECONDARY HAM-A |
-5.7 | — |
| SECONDARY Beck Scale for Suicidal Ideation (BSI) |
-2.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01882829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.