SONRISA: Study of Neural Responses Induced by Antidepressant Effects

Sponsor

Marta Peciña, MD PhD (Other)

Overall Status

Completed

CT.gov ID

NCT02674529

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Escitalopram Drug: Placebo	Phase 2/Phase 3

Detailed Description

Over the past decade, neuroimaging tools have rapidly advanced the field of neural biomarkers of treatment response in depression. Still, despite obvious scientific progress in this field, the ability to implement neuroimaging biomarkers of antidepressant treatment response in clinical trial settings is lacking. In order to objectively asses the neural bases of treatment response in depression, the investigators will use a "Real-time Neurofeedback fMRI task", specifically designed to record and modulate mood improvement by providing neurofeedback in the context of the administration of an antidepressant treatment. In a pilot study, positive neurofeedback during the administration of the drug was associated with significant acute mood improvement and increased blood oxygen level dependent (BOLD) responses in the rostral anterior cingulate cortex (rACC), a common neural target of antidepressant treatments. The central hypothesis is that antidepressant effects in depression are mediated by increased neural activity in the rACC (AIM1), which can be used in clinical trials of antidepressant treatment to predict antidepressant effects (AIM 2) and assess the effect of antidepressant treatment on antidepressant-induced rACC neural responses (AIM 3). The results obtained from this project are expected to have an important impact on our ability to understand the cognitive and neural mechanisms implicated in antidepressant treatment responses in patients with depression, as well as on the ability to implement neuroimaging biomarkers of treatment response in the clinical trial settings.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Study of Neural Responses Induced by Simulated Antidepressants

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antidepressant Treatment 20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.	Drug: Escitalopram Selective Serotonin Reuptake Inhibitor (SSRI) Other Names: Lexapro
Placebo Comparator: Placebo A placebo pill will be taken over an 8-week period.	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: Antidepressant Treatment

20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.

Drug: Escitalopram

Selective Serotonin Reuptake Inhibitor (SSRI)

Other Names:

Lexapro

Placebo Comparator: Placebo

A placebo pill will be taken over an 8-week period.

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS) [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.[2] There is, however, a high degree of statistical correlation between scores on the two measures.
Quick Inventory of Depressive Symptomatology (QIDS) [8 weeks]
16-item self-reported depression questionnaire.

Secondary Outcome Measures

Neural Responses (Blood oxygen dependent level response to neurofeedback signal). [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

A man or woman age of 18 or older.
Currently experiencing a depressive episode as part of Major Depressive Disorder.
Able to tolerate lying still on your back for 60 minutes at a time.
Have had no more than one failed antidepressant trial of adequate dose and duration.
Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)

Exclusion Criteria:

Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.
Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression
Pregnant or breastfeeding or plan to become pregnant over the duration of the study.
Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.
Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 months.
Have a medical condition that contradicts treatment with escitalopram.
Are currently receiving psychotherapy or any other treatment for your depression.