Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression
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ClinicalTrials.gov Identifier: NCT00215228 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : July 21, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: duloxetine vs. escitalopram | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control |
Study Start Date : | July 2005 |
Actual Study Completion Date : | August 2007 |

- Effect of treatment on heart rate variability
- Effect of treatment on affective variables (depression, anxiety, stress reactivity)
- Effect of treatment on neurotransmitter transporter occupancy

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults 20-60 years of age
- a primary diagnosis of depression using DSM-IV criteria
- written informed consent
- a negative serum pregnancy test for women of childbearing potential
Exclusion Criteria:
- history of cardiovascular disease
- history of hypertension
- history of bipolar disorder
- history of schizophrenia or other psychotic disorder
- alcohol or other substance abuse within the last 3 months
- history of cognitive impairment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215228
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Wei Zhang, M.D., Ph. D | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00215228 |
Other Study ID Numbers: |
Pro00007159 6957-05-3R0 ( Other Identifier: DUMC ) |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | July 21, 2014 |
Last Verified: | September 2007 |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders Duloxetine Hydrochloride Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Peripheral Nervous System Agents Serotonin and Noradrenaline Reuptake Inhibitors Analgesics Sensory System Agents Dopamine Agents |