Depression
Conditions
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
Brief 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.
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.
Interventions
DRUGEscitalopram
20 mg target dose for 12 weeks
OTHERMagnetic Resonance Imaging
Structural and functional MRI of the brain for research purposes.
Sponsors
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity (Measured by Hamilton Depression Rating Scale) | 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MDD (Escitalopram Tx) Target dose 20mg for 12 weeks
Escitalopram: 20 mg target dose for 12 weeks | 54 |
| Control No treatment (healthy comparison participants with no history or presence of psychiatric disorder) | 67 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Family Member Request | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Perceived Medication Side Effects | 4 | 0 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | MDD (Escitalopram Tx) | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 58 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Continuous | 71.76 years STANDARD_DEVIATION 6.77 | 72.36 years STANDARD_DEVIATION 6.17 | 72.09 years STANDARD_DEVIATION 6.43 |
| Diagnostic Status | 54 Participants | 67 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 67 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 60 Participants | 108 Participants |
| Region of Enrollment United States | 54 participants | 67 participants | 121 participants |
| Sex/Gender, Customized Female | 33 Participants | 39 Participants | 72 Participants |
| Sex/Gender, Customized Male | 21 Participants | 28 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 67 |
| other Total, other adverse events | 9 / 54 | 3 / 67 |
| serious Total, serious adverse events | 0 / 54 | 2 / 67 |
Outcome results
Primary
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.
Time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escitalopram | Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) | Baseline Depression Severity | 25.26 score on a scale | Standard Deviation 4.65 |
| Escitalopram | Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) | Week 12 Depression Severity | 13.78 score on a scale | Standard Deviation 9.07 |
| Control | Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) | Baseline Depression Severity | 1.03 score on a scale | Standard Deviation 1.36 |
| Control | Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale) | Week 12 Depression Severity | 1.08 score on a scale | Standard Deviation 1.43 |
p-value: <0.025Mixed Models Analysis
Secondary
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.
Time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
Population: 4 participants in the Escitalopram group and 3 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Escitalopram | Change in Depression Severity (Measured by Hamilton Depression Rating Scale) | Baseline Depression Severity | 23.48 score on a scale | Standard Deviation 4.45 |
| Escitalopram | Change in Depression Severity (Measured by Hamilton Depression Rating Scale) | Week 12 Depression Severity | 12.44 score on a scale | Standard Deviation 8.49 |
| Control | Change in Depression Severity (Measured by Hamilton Depression Rating Scale) | Week 12 Depression Severity | 1.52 score on a scale | Standard Deviation 1.69 |
| Control | Change in Depression Severity (Measured by Hamilton Depression Rating Scale) | Baseline Depression Severity | 1.24 score on a scale | Standard Deviation 1.32 |
p-value: <0.025Mixed Models Analysis