Clinical trial NCT02674529: Study of Neural Responses Induced by Antidepressant Effects
Official title: Study of Neural Responses Induced by Simulated Antidepressants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Neuroimaging biomarkers
MDD
Neurofeedback
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
timeFrame: baseline and week 8
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
timeFrame: baseline and 8 weeks
measure: Neural Responses During the Sham Neurofeedback fMRI Task.
timeFrame: Baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: WPIC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Marta Pecina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: