Study of Neural Responses Induced by Antidepressant Effects

NCT ID: NCT02674529

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-05-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Antidepressant Treatment

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

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

Selective Serotonin Reuptake Inhibitor (SSRI)

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

Intervention Type: BEHAVIORAL

Placebo experiment during an fMRI scanning session

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

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

Intervention Type: BEHAVIORAL

Placebo experiment during an fMRI scanning session

Interventions

Escitalopram

Selective Serotonin Reuptake Inhibitor (SSRI)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

Placebo experiment during an fMRI scanning session

Intervention Type: BEHAVIORAL

Other Intervention Names

Lexapro

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marta Peciña, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Marta Peciña, MD PhD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Pecina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

WPIC

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19070392/PRO16050131

Identifier Type: -

Identifier Source: org_study_id