DepressionPhase 4NCT01728194

Emotional and Cognitive Control in Late-Onset Depression

A Phase 4 study testing Escitalopram and Magnetic Resonance Imaging in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study may help identify how abnormalities in brain systems that control the ability to ignore irrelevant information may contribute to the development of depression in older adults. Read more about this study

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Escitalopram and Magnetic Resonance Imaging
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 2 sitesUnited States
Study dates: Jul 2012to 31 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age: 60-85 years, right-handed;
Diagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);
Age of onset of first episode ≥ 50 years with up to three depressive episodes;
Severity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) ≥ 20.

Who cannot join

Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher than 2;
High suicide risk, i.e. intent or plan to attempt suicide in near future;
Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse;
History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
Dementia: Diagnosis of dementia by DSM-IV;
Mild Cognitive Impairment (MCI);

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Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or use of drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;
Neurological brain disease and/or history of electroconvulsive therapy;
History of any use of citalopram or escitalopram during the current episode or need for drugs that may interact with these agents, i.e. drug metabolized by the 2D6 P450 isoenzyme system;
Current involvement in psychotherapy;
Contraindications to MRI scanning including cardiac pacemaker, metallic objects and metallic implants contraindicating MRI, cardiac stent, claustrophobia;
Inability to speak English;
Corrected visual acuity < 20/70; Color blindness.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Weill Cornell Medical College
New York, New York, 10065
Weill Cornell Medical College - Westchester Division
White Plains, New York, 10605

Other trials in United States

About this study

Official title: White Matter and Emotional and Cognitive Control in Late-Onset Depression

This study may help identify how abnormalities in brain systems that control the ability to ignore irrelevant information may contribute to the development of depression in older adults.

Read the detailed description

Approximately half of those who develop depression in late life never had depression before. The classic view is that changes taking place in our brains as we age contribute to the development of late-onset depression. This view is supported by the relative absence of family history for those with late onset depression. This research study will recruit 70 older adults with late life depression and 70 older adults without depression. All participants will receive a sub-clinical, non-contrast (magnetic resonance imaging (MRI) scan at the beginning of the study and then again 12 weeks later at the completion of the study. The depressed older participants will also receive a Food and Drug Administration (FDA)-approved antidepressant, escitalopram (Lexapro), as treatment for their depressive symptoms over 12 weeks. This MRI study may help the researchers identify how abnormalities in brain systems that control our ability to ignore distractions, control our emotions, and anticipate reward may contribute to the development of depression in older adults. The investigators hope that the findings promote the development of tests that may improve the detection of older adults at risk for poor treatment outcomes and eventually guide the development of novel treatments for depression.

Conditions: Depression
Being tested: Escitalopram, Magnetic Resonance Imaging
Keywords: Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Escitalopram, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Physiological Effects of Drugs, Muscarinic Antagonists, Antidepressive Agents, Psychotropic Drugs, Serotonin Uptake Inhibitors, Neurotransmitter Uptake Inhibitors, Serotonin Agents, Magnetic Resonance Imaging, Functional, fMRI, Magnetic Resonance Imaging
Medical subject headings: Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Also called Lexapro, 76184942
20 mg target dose for 12 weeks
Magnetic Resonance ImagingOther
Also called MRI
Structural and functional MRI of the brain for research purposes.

Study groups in NCT01728194
Study group	Role	What they receive
Escitalopram	Experimental	Target dose 20mg for 12 weeks Receives: Drug: Escitalopram; Other: Magnetic Resonance Imaging
Control	Other	Non-psychiatric comparison participants. Receives: Other: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.
Measured: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Secondary outcomes (1)

Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.
Measured: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201231 Jul 2019

First posted16 Nov 2012 (estimated)
Study startJul 2012
Primary completion31 Jul 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728194
Sponsor's protocol ID: 1205012392
Other IDs: 1R01MH097735-01
Status last verified: Sep 2020
First submitted: 12 Nov 2012
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Victoria LW, Alexopoulos GS, Ilieva I, Stein AT, Hoptman MJ, Chowdhury N, Respino M, Morimoto SS, Kanellopoulos D, Avari JN, Gunning FM. White matter abnormalities predict residual negative self-referential thinking following treatment of late-life depression with escitalopram: A preliminary study. J Affect Disord. 2019 Jan 15;243:62-69. doi: 10.1016/j.jad.2018.09.013. Epub 2018 Sep 11.
PubMed 30236759
Oberlin LE, Victoria LW, Ilieva I, Dunlop K, Hoptman MJ, Avari J, Alexopoulos GS, Gunning FM. Comparison of Functional and Structural Neural Network Features in Older Adults With Depression With vs Without Apathy and Association With Response to Escitalopram: Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2224142. doi: 10.1001/jamanetworkopen.2022.24142.
PubMed 35895056
Respino M, Hoptman MJ, Victoria LW, Alexopoulos GS, Solomonov N, Stein AT, Coluccio M, Morimoto SS, Blau CJ, Abreu L, Burdick KE, Liston C, Gunning FM. Cognitive Control Network Homogeneity and Executive Functions in Late-Life Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):213-221. doi: 10.1016/j.bpsc.2019.10.013. Epub 2019 Nov 7.
PubMed 31901436
Respino M, Jaywant A, Kuceyeski A, Victoria LW, Hoptman MJ, Scult MA, Sankin L, Pimontel M, Liston C, Belvederi Murri M, Alexopoulos GS, Gunning FM. The impact of white matter hyperintensities on the structural connectome in late-life depression: Relationship to executive functions. Neuroimage Clin. 2019;23:101852. doi: 10.1016/j.nicl.2019.101852. Epub 2019 May 3.
PubMed 31077981

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: White Matter and Emotional and Cognitive Control in Late-Onset Depression
ClinicalTrials.gov ID: NCT01728194
Acronym / sponsor ID: 1205012392
Conditions: Depression
Keywords: Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Escitalopram, Central Nervous System Agents, Therapeutic Uses
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jul 2012 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 16 Nov 2012 (estimated)
Results: Posted 6 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study may help identify how abnormalities in brain systems that control the ability to ignore irrelevant information may contribute to the development of depression in older adults.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Escitalopram	Experimental	Drug: Escitalopram, Other: Magnetic Resonance ImagingTarget dose 20mg for 12 weeks
Control	Other	Other: Magnetic Resonance ImagingNon-psychiatric comparison participants.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age: 60-85 years, right-handed;
Diagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);
Age of onset of first episode ≥ 50 years with up to three depressive episodes;
Severity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) ≥ 20.

Key exclusion criteria (13 listed)

Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher than 2;
High suicide risk, i.e. intent or plan to attempt suicide in near future;
Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse;
History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
Dementia: Diagnosis of dementia by DSM-IV;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EscitalopramAlso: Lexapro, 7618494220 mg target dose for 12 weeks	Drug	Escitalopram
Magnetic Resonance ImagingAlso: MRIStructural and functional MRI of the brain for research purposes.	Other	Control, Escitalopram

Primary outcome

Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
Time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.

1 secondary outcome

Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
Time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

Results and safety

Results posted to the registry on 6 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MDD (Escitalopram Tx)	54	34
Control	67	61

Primary outcome: Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)

Time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx). Mean (Standard Deviation). Unit: score on a scale

Measure	Escitalopram n = 54	Control n = 67
Baseline Depression Severity	25.26 (4.65)	1.03 (1.36)
Week 12 Depression Severity	13.78 (9.07)	1.08 (1.43)

Escitalopram vs Control: p < 0.025, Mixed Models Analysis

Population analysed: 4 participants in the Escitalopram group and 4 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline (Study Entry) through 12 Weeks of Treatment/Participation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MDD (Escitalopram Tx)	0 of 54 (0%)	9 of 54 (16.7%)	0 of 54
Control	2 of 67 (3%)	3 of 67 (4.5%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30236759Victoria LW, Alexopoulos GS, Ilieva I, Stein AT, Hoptman MJ, Chowdhury N, Respino M, Morimoto SS, Kanellopoulos D, Avari JN, Gunning FM. White matter abnormalities predict residual negative self-referential thinking following treatment of late-life depression with escitalopram: A preliminary study. J Affect Disord. 2019 Jan 15;243:62-69. doi: 10.1016/j.jad.2018.09.013. Epub 2018 Sep 11.
Derived from this study: PubMed 35895056Oberlin LE, Victoria LW, Ilieva I, Dunlop K, Hoptman MJ, Avari J, Alexopoulos GS, Gunning FM. Comparison of Functional and Structural Neural Network Features in Older Adults With Depression With vs Without Apathy and Association With Response to Escitalopram: Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2224142. doi: 10.1001/jamanetworkopen.2022.24142.
Derived from this study: PubMed 31901436Respino M, Hoptman MJ, Victoria LW, Alexopoulos GS, Solomonov N, Stein AT, Coluccio M, Morimoto SS, Blau CJ, Abreu L, Burdick KE, Liston C, Gunning FM. Cognitive Control Network Homogeneity and Executive Functions in Late-Life Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):213-221. doi: 10.1016/j.bpsc.2019.10.013. Epub 2019 Nov 7.
Derived from this study: PubMed 31077981Respino M, Jaywant A, Kuceyeski A, Victoria LW, Hoptman MJ, Scult MA, Sankin L, Pimontel M, Liston C, Belvederi Murri M, Alexopoulos GS, Gunning FM. The impact of white matter hyperintensities on the structural connectome in late-life depression: Relationship to executive functions. Neuroimage Clin. 2019;23:101852. doi: 10.1016/j.nicl.2019.101852. Epub 2019 May 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Faith Gunning, Ph.D. principal investigator

Weill Medical College of Cornell University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram and Magnetic Resonance Imaging in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) (time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728194, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.