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Completed

NCT Number: NCT02674529

Study of Neural Responses Induced by Antidepressant Effects

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

WPIC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Selective Serotonin Reuptake Inhibitor (SSRI)

Other names: Lexapro

Placebo

Drug

Placebo

Real-time Neurofeedback fMRI task pre- and post-RCT

Behavioral

Placebo experiment during an fMRI scanning session

Primary outcomes

  1. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores

    Time frame: baseline and week 8

    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.

Secondary outcomes

  1. Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores

    Time frame: baseline and 8 weeks

    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).

  2. Neural Responses During the Sham Neurofeedback fMRI Task.

    Time frame: Baseline

    Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.

Sponsors and collaborators

Lead sponsor

Marta Peciña, MD PhD

Other

Registry information

Official study title

Study of Neural Responses Induced by Simulated Antidepressants

Acronym: SONRISA

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2016
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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