Study of Neural Responses Induced by Antidepressant Effects (SONRISA)
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|ClinicalTrials.gov Identifier: NCT02674529|
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Study of Neural Responses Induced by Simulated Antidepressants|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Antidepressant Treatment
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Selective Serotonin Reuptake Inhibitor (SSRI)
Other Name: Lexapro
Placebo Comparator: Placebo
A placebo pill will be taken over an 8-week period.
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was. There is, however, a high degree of statistical correlation between scores on the two measures.
- Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 8 weeks ]16-item self-reported depression questionnaire.
- Neural Responses (Blood oxygen dependent level response to neurofeedback signal). [ Time Frame: Baseline and 8-weeks ]Scanning sessions are 90 minutes long. Scans are of the brain during the administration of an FDA-approved fast-acting antidepressant treatment. The investigators will determine the relationship between acute mood improvement and neural responses to positive neurofeedback versus the clinical response [∆ in Montgomery-Asberg Depression Rating Scale (MADRS) scores] to 8 weeks of placebo treatment in 35 patients with MDD.
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): NCT02674529
|Contact: Thandi Lyew||(412) 246 - email@example.com|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Thandi Lyew 412-246-6147 firstname.lastname@example.org|