Diabetes Mellitus Clinical Trial
— EFDIDOfficial title:
Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label
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 pain symptoms
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive symptoms | 14 weeks | No | |
Secondary | Diabetes self-care | 14 weeks | No |
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