Study of Neural Responses Induced by Antidepressant Effects

NCT02674529 | Completed Phase 2 Results DMC

• 1 other identifier: STUDY19070392/PRO16050131
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Neuroimaging biomarkers; MDD; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores

  baseline and 8 weeks

• Neural Responses During the Sham Neurofeedback fMRI Task.

  Baseline

Study Arms (2)

Antidepressant Treatment

ACTIVE COMPARATOR

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

Drug: Escitalopram; Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT

Interventions

Escitalopram DRUG

Selective Serotonin Reuptake Inhibitor (SSRI)

Also known as: Lexapro

Antidepressant Treatment

Placebo DRUG

Placebo

Placebo

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

Placebo experiment during an fMRI scanning session

Antidepressant Treatment; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marta Peciña, MD PhD: lead

Study Sites (1)

WPIC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Project Research Coordinator
• Organization: University of Pittsburgh

neppacham@upmc.edu

412-376-3913

Study Officials

• Marta Pecina, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 4, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)