Escitalopram (Lexapro) for Depression MS or ALS
This study has been completed.
Sponsor:
University of South Carolina
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT00965497
First received: August 7, 2009
Last updated: August 4, 2011
Last verified: August 2011
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Purpose
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis |
Drug: escitalopram |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by University of South Carolina:
Primary Outcome Measures:
- Hamilton Depression Scale (HAM-D 17). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- McGill Quality of Life Scale (MQOL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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).
| Enrollment: | 13 |
| Study Start Date: | July 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Escitalopram
All patients will receive escitalopram 20 mg daily.
|
Drug: escitalopram
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.
Other Name: Lexapro
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965497
Locations
| United States, South Carolina | |
| University of South Carolina School of Medicine | |
| Columbia,, South Carolina, United States, 20203 | |
Sponsors and Collaborators
University of South Carolina
Investigators
| Principal Investigator: | Meera Narasimhan, MD | University of South Carolina School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Meera Narasimhan, MD, University of South Carolina School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00965497 History of Changes |
| Other Study ID Numbers: | LXP-113 |
| Study First Received: | August 7, 2009 |
| Results First Received: | April 19, 2011 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Carolina:
|
Amyotrophic Lateral Sclerosis ALS Multiple Sclerosis MS Major Depression |
Depression Major Depressive Disorder antidepressants Escitalopram Lexapro |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Depression Depressive Disorder Multiple Sclerosis Sclerosis Depressive Disorder, Major Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases |
Behavioral Symptoms Mood Disorders Mental Disorders Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013