Nuedexta in Treatment-Resistant Major Depression
|ClinicalTrials.gov Identifier: NCT01882829|
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Treatment Resistant||Drug: dextromethorphan/quinidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting the NMDA Glutamate Receptor as Novel Antidepressant Strategy: A Pilot Clinical Trial of Nuedexta in Treatment-Resistant Major Depression|
|Study Start Date :||July 2013|
|Primary Completion Date :||March 2016|
|Study Completion Date :||March 2016|
Experimental: Nuedexta (dextromethorphan/quinidine)
45/10 mg every 12 hours x 8 weeks
up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects
Other Name: Nuedexta
- Change in Montgomery-Asberg Depression Rating Scale [ Time Frame: At baseline and visit 6 (week 10) ]
The Montgomery-Asberg Depression Rating Scale is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS is specifically designed to detect changes in depression severity in the context of a medication treatment trial and is the used as the primary outcome of the current study.
Primary outcome is change in MADRS at Visit 6 (Week 10)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form [ Time Frame: At baseline and Visit 6 (week 10) ]The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form is a reliable and valid self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by individuals.
- Change in Range of Impaired Functioning Tool [ Time Frame: At baseline and Visit 6 (week 10) ]The Range of Impaired Functioning Tool a brief scale for assessing functional impairment related to medical or psychiatric illness and has been demonstrated to possess good psychometric properties.
- Change in Sheehan Disability Scale [ Time Frame: At baseline and Visit 6 (week 10) ]The Sheehan Disability Scale is a self-rated scale which assesses illness-related disability in three areas of functioning: work, social and family.
- Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: up to 12 weeks ]Frequency of observed adverse events over the study treatment period as captured by the PRISE. The Patient Rated Inventory of Side Effects (PRISE) assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other).
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 12 weeks ]The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors.
- Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) [ Time Frame: up to 12 weeks ]The Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) is a 16-item self rated instrument designed to assess the severity of depressive symptoms (30). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).
- Clinical Global Impression (CGI) scale [ Time Frame: up to 12 weeks ]The Clinical Global Impression (CGI) scale assesses overall treatment response in psychiatric patients and has good reliability and validity metrics. The administration time is 2 minutes. This scale consists of three items: Severity of Illness (item 1); Global Improvement (item 2); and Efficacy Index (item 3). Item 1 is rated on a seven-point scale (1 = normal, 7 = among the most extremely ill patients) as is item 2 (1 = very much improved, 7 = very much worse).
- Change in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: At baseline and Visit 6 (week 10) ]The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a brief scale to measure cognitive and executive dysfunction in mood and anxiety disorders, and possesses good reliability and validity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882829
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||James Murrough, MD||Icahn School of Medicine at Mount Sinai|