Depression
Conditions
Keywords
Depression
Brief summary
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.
Detailed description
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
Interventions
DRUGEscitalopram
10mg tab daily
Sponsors
National Institute of Mental Health (NIMH)
Forest Laboratories
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60). 2. Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions. 3. Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).
Exclusion criteria
1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51). 2. High suicide risk, i.e. intent or plan to attempt suicide in near future. 3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression. 4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV). 5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale. | 14 weeks (12th week of treatment) | A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales. |
| WHODAS-II Disability Scale | 14 weeks (12th week of treatment) | A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales. |
| Stroop Color-Word Test | 14 weeks (12th week of treatment) | A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales. |
Participant flow
Recruitment details
Participant Flow of the Overall Study
Pre-assignment details
116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram 12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Phase | Lack of Efficacy | 6 |
| Treatment Phase | Lost to Follow-up | 2 |
| Treatment Phase | Physician Decision | 8 |
| Treatment Phase | Protocol Violation | 1 |
| Treatment Phase | Withdrawal by Subject | 8 |
| Two Week Drug Washout and Placebo Phase | Placebo Reponder | 16 |
Baseline characteristics
| Characteristic | Escitalopram |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 69 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 70.82 Years STANDARD_DEVIATION 6.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hamilton Scale for Depression | 21.21 units on a scale STANDARD_DEVIATION 4.51 |
| Mini Mental Status Examination (MMSE) | 28.08 units on a scale STANDARD_DEVIATION 1.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 75 Participants |
| Region of Enrollment United States | 90 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 39 Participants |
| Stroop Color-Word Test | 32.77 units on a scale STANDARD_DEVIATION 10.63 |
| WHODAS-II Disability Score | 34.64 units on a scale STANDARD_DEVIATION 10.56 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 55 / 90 |
| serious Total, serious adverse events | 6 / 90 |
Outcome results
Primary
Hamilton Depression Rating Scale.
A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Time frame: 14 weeks (12th week of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Hamilton Depression Rating Scale. | 8.09 units on a scale | Standard Deviation 5.93 |
Primary
Stroop Color-Word Test
A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
Time frame: 14 weeks (12th week of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Stroop Color-Word Test | 33.63 units on a scale | Standard Deviation 10.2 |
Primary
WHODAS-II Disability Scale
A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Time frame: 14 weeks (12th week of treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram | WHODAS-II Disability Scale | 31.43 units on a scale | Standard Deviation 9.14 |