Amyotrophic Lateral Sclerosis, Major Depression, Multiple Sclerosis
Conditions
Keywords
Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants, Escitalopram, Lexapro
Brief summary
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
Detailed description
This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.
Interventions
DRUGescitalopram
After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.
Sponsors
University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 70 years of age with documented ALS or MS, * DSM-IV episode of non-psychotic Major Depression, * ≥14 score on the 17-item HAM-D, * Ability to give informed consent.
Exclusion criteria
* History of psychotic disorders, * Psychotic depression, * Bipolar depression, * Suicide risk, * History of substance abuse in the previous 6 months, * History of unstable medical disorders, * Pregnancy or planning for pregnancy, * Severity of ALS or MS that limits participating in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAM-D 17). | 8 weeks | Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McGill Quality of Life Scale (MQOL) | 8 weeks | McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent). |
Countries
United States
Participant flow
Recruitment details
Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.
Pre-assignment details
Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Open-label, Single Arm All patients will receive the intervention | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Open-label, Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Hamilton Depression Scale (HAM-D 17).
Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.
Time frame: 8 weeks
Population: Intention to Treat
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Escitalopram | Hamilton Depression Scale (HAM-D 17). | 15 depression severity | Standard Deviation 7 |
Comparison: There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.p-value: 0.01t-test, 2 sided
Secondary
McGill Quality of Life Scale (MQOL)
McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Escitalopram | McGill Quality of Life Scale (MQOL) | 5 quality of life |