Clinical trial NCT00650897: Efficacy Study of Escitalopram for Depression in Patients With Diabetes
Official title: Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depression
Diabetes Mellitus
Keywords: Efficacy
Antidepressant
Escitalopram
Major Depression
Diabetes Mellitus
Self Care
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 pain symptoms

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 disability, more frequent medical complications, greater healthcare utilization costs, poorer glycemic control, and greater difficulties with diabetes self-care activities, compared with patients with diabetes without depression. Few specific features of Escitalopram, a selective serotonin reuptake inhibitor (SSRI), make it a promising medication for use in diabetes. These include a benign side effect profile; high tolerance in elderly patients; rapid action with efficacy often demonstrated in as little 1-2 weeks, which in turn could help improve compliance; its efficacy for treatment of generalized anxiety disorder, which may also be relatively common in patients with diabetes, and co-occurs frequently with depression. This study is designed to test the efficacy of Escitalopram for the treatment of major depression in patients with diabetes mellitus.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: 14 weeks
Secondary outcomes:
measure: Diabetes self-care
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: The Gertner Institute
name: Raz Gross, MD; MPH
role: PRINCIPAL_INVESTIGATOR
References: