Phase 4
Completed N=121
Emotional and Cognitive Control in Late-Onset Depression
Source: ClinicalTrials.gov NCT01728194 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Oct 2020
Primary outcomePrimary: Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) — 25.26; 1.03; 13.78; 1.08 score on a scale — p=< 0.025
◆ Published Evidence
Established
72citations · ~10 / year
The impact of white matter hyperintensities on the structural connectome in late-life depression: Relationship to executive functions.
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.
Linked Publications (3)
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The impact of white matter hyperintensities on the structural connectome in late-life depression: Relationship to executive functions.
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Cognitive Control Network Homogeneity and Executive Functions in Late-Life Depression.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) |
25.26; 1.03; 13.78; 1.08 | < 0.025 sig |
| SECONDARY Change in Depression Severity (Measured by Hamilton Depression Rating Scale) |
23.48; 1.24; 12.44; 1.52 | <0.025 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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);
- 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.
Data sourced from ClinicalTrials.gov (NCT01728194) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.