Study to Treat Major Depressive Disorder With a New Medication
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|ClinicalTrials.gov Identifier: NCT03043560|
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder Anhedonia||Drug: Ezogabine Drug: Placebos||Phase 2|
Depressive disorders are among the most disabling medical conditions worldwide and currently available treatments fall short of addressing this large public health burden. Dysfunction within the brain reward system is emerging as a core feature of depressive disorders, in particular related to deficits in motivation, interest, and response to pleasure (e.g., anhedonia: markedly diminished response to pleasure). Evidences from a series of preclinical studies from our group highlighted the KCNQ subtype of neuronal potassium (K+) channel as a novel target for the treatment of depressive disorders and our human pilot study showed a reduction in anhedonia and related symptoms, and an increased brain response to reward (as measured by functional magnetic resonance imaging [fMRI]) following treatment with ezogabine. Building on this data, the current project will assess reward circuit activity following treatment with ezogabine in depressed patients with a current depressive disorder (Major depressive disorder [MDD], persistent depressive disorder, other specified depressive disorder) and anhedonia (defined by a score ≥ 20 on the Snaith-Hamilton Pleasure Scale [SHAPS]), using fMRI to investigate the cortico-striatal circuit to reward.
This study represents the first part of the R61/R33 National Institutes of Health (NIH) founded project. A clear increase in reward circuit activation in at least one ezogabine treatment group compared to placebo, given acceptable tolerability, will constitute a "go" and the project will move to the next phase (R33), where we aim to examine the relationship between treatment, reward circuit activity, and behavioral and clinical outcomes in a larger, confirmatory efficacy trial of ezogabine for depression with anhedonia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind|
|Official Title:||Developing Neuronal KCNQ Channel Modulators for Mood Disorders|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Participants will receive treatment with ezogabine up to 900mg/day.
daily for 5 weeks
Other Name: Potiga
Placebo Comparator: Placebo
Participants will receive treatment with a matching placebo pill.
placebo pill daily for 5 weeks
- Change in the cortico-striatal circuit response [ Time Frame: baseline and 5 weeks ]Change in the cortico-striatal circuit response to reward after at least one week treatment with the maximum dosage of ezogabine at baseline and after 5 weeks of treatment.
- Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 5 weeks ]14-item self-report questionnaire commonly used to assess anhedonia.
- Clinical Global Impression - Improvement (CGI-I0 [ Time Frame: 5 weeks ]A widely administered clinician rated global measure of the degree of improvement from the initial assessment in subject overall illness severity.
- Clinical Global Impression - Severity (CGI-S) [ Time Frame: 5 weeks ]Clinician rated global measure of subject overall illness severity.
- Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) [ Time Frame: 5 weeks ]A measure specifically designed to assess hedonic capacity for social and interpersonal pleasure.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 5 weeks ]A 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms.
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 5 weeks ]A 12-item generic assessment instrument that measures investigating the level of functioning in six domains: Cognition, Mobility, Self-care, Getting along, Life activities, and Participation.
- Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: 5 weeks ]The TEPS is an 18-item self-report measurement of anticipatory (10 items) and consummatory (eight items) components of anhedonia which consists of a series of statements that must be rated according to how accurate they are for the individual.
- Specific Loss of Interest and Pleasure Scale (SLIPS) [ Time Frame: 5 weeks ]The SLIPS is a recently developed and validated measure of anhedonia that is tailored to detect recent changes in anhedonia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043560
|Contact: Morgan Harnoisfirstname.lastname@example.org|
|Contact: Sara Costi, MDemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Morgan Harnois 212-241-3089 firstname.lastname@example.org|
|Principal Investigator: James Murrough, MD, PhD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Tabish Iqbal 713-798-4095 email@example.com|
|Principal Investigator: SanJay Mathew, MD|
|Principal Investigator:||James Murrough, MD, PhD||Icahn School of Medicine at Mount Sinai|