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Study of Neural Responses Induced by Antidepressant Effects (SONRISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02674529
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : February 7, 2019
Information provided by (Responsible Party):
Marta Peciña MD PhD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Drug: Placebo Phase 2 Phase 3

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 asses 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of Neural Responses Induced by Simulated Antidepressants
Study Start Date : September 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Active Comparator: Antidepressant Treatment
20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.
Drug: Escitalopram
Selective Serotonin Reuptake Inhibitor (SSRI)
Other Name: Lexapro

Placebo Comparator: Placebo
A placebo pill will be taken over an 8-week period.
Drug: Placebo

Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
    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.

  2. Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 8 weeks ]
    16-item self-reported depression questionnaire.

Secondary Outcome Measures :
  1. Neural Responses (Blood oxygen dependent level response to neurofeedback signal). [ Time Frame: Baseline and 8-weeks ]
    Scanning sessions are 90 minutes long. Scans are of the brain during the administration of an FDA-approved fast-acting antidepressant treatment. The investigators will determine the relationship between acute mood improvement and neural responses to positive neurofeedback versus the clinical response [∆ in Montgomery-Asberg Depression Rating Scale (MADRS) scores] to 8 weeks of placebo treatment in 35 patients with MDD.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02674529

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Contact: Thandi Lyew (412) 246 - 6147

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United States, Pennsylvania
WPIC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Thandi Lyew    412-246-6147   
Sponsors and Collaborators
University of Pittsburgh

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Responsible Party: Marta Peciña MD PhD, MD PhD, University of Pittsburgh Identifier: NCT02674529     History of Changes
Other Study ID Numbers: PRO16050131
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study will follow NIMH schedule for data sharing for clinical trials. The schedule allows for descriptive data to be submitted - but not shared - ongoing and results associated with a finding - both positive and negative - to be submitted prior to the communication of a result. Once a result is communicated, either through publication and/or on the NDCT website the data specifically defined to the clinical trial will then be shared.
Keywords provided by Marta Peciña MD PhD, University of Pittsburgh:
Neuroimaging biomarkers
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents