Status:
UNKNOWN
Efficacy Study of Escitalopram for Depression in Patients With Diabetes
Lead Sponsor:
Sheba Medical Center
Conditions:
Major Depression
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with diabetes and major depression treated with Escitalopram might experience significant improvement in depression and anxiety scores; functional ability; diabetes-related self-care; and pai...
Detailed Description
Major depression is common in patients diabetes (point prevalence about 15-20%). It has been shown that patients with diabetic and major depression experience more severe diabetes symptoms, greater di...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Diagnosis of Type-1 or Type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study.
- Current diagnosis of major depression based on DSM-IV criteria .
- Hamilton Depression Rating Scale (HAMD) baseline score \> 17
- Available for 14-weeks of treatment and all evaluations.
- Able to understand study rules and procedures and willing to sign written informed consent for study participation.
Exclusion
- Competence: Not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.
- Psychiatric exclusions: One or more of the following: Alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts.
- Medical exclusions: Known intolerance or hypersensitivity to escitalopram or other SSRI; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg); any acute or unstable medical condition that might interfere with the safe conduct of the study.
- Concomitant medication(s) exclusion: Current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00650897
Start Date
April 1 2008
End Date
October 1 2009
Last Update
April 2 2008
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel