Study of Neural Responses Induced by Antidepressant Effects

Major Depressive Disorder Clinical Trial

— SONRISA  

Official title:

Study of Neural Responses Induced by Simulated Antidepressants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674529
• Other study ID #: STUDY19070392/PRO16050131
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Est. completion date: May 2021

Study information

• Verified date: October 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 assess 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
Selective Serotonin Reuptake Inhibitor (SSRI)
• Placebo
Placebo

Behavioral:
• Real-time Neurofeedback fMRI task pre- and post-RCT
Placebo experiment during an fMRI scanning session

Locations

Country	Name	City	State
United States	WPIC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marta Peciña, MD PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores	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.	baseline and week 8
Secondary	Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores	The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression).	baseline and 8 weeks
Secondary	Neural Responses During the Sham Neurofeedback fMRI Task.	Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.	Baseline