Medications for the Treatment of Dysthymic Disorder and Double Depression
Recruitment status was Active, not recruiting
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Purpose
The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Dysthymia |
Drug: escitalopram and sertraline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Escitalopram Vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression |
- score on first 17 items of HAM-D Rating Scale 24 item, each visit
- scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | October 2006 |
Dysthymic Disorder is a common, chronic type of depression that is often seen as a mild condition and is under-treated. Because of its chronic course, it is often complicated by episodes of major depression and may require long-term treatment.
This is a twelve week study during which daily doses of escitalopram (10-20 mg) or sertraline (50-200 mg) will be given to outpatients meeting criteria for Dysthymic Disorder or Double Depression. Medications will be assigned 1:1 and clinicians will be blinded to treatment. Efficacy will be based on scores for the Hamilton Depression Rating Scale, patient subjective reporting, and clinician observation. The study will have a total of 8 visits over 12 weeks, with a one-week medication taper period at the end. Subjects will have a physical exam, labs, and vital signs monitored at first visit and vital signs monitored at every subsequent visit. Women of childbearing potential must have a negative urine pregnancy test at screening. All subjects will remain on the lowest medication dose for the first four weeks of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary diagnosis of Dysthymic Disorder or Major Depressive Disorder with Antecedent Dysthymia
- Women of childbearing potential must have negative pregnancy test at screen and agree to practice acceptable method of birth control
- Score of at least 12 on the 24-item Hamilton Depression Scale at study entry
- Initial screening labs grossly within normal limits
- Signed written informed consent
Exclusion Criteria:
- Other Axis-I diagnoses such as delirium, dementia, and substance dependence (active in last year) or any substance abuse including alcohol within the past six months
- Actively suicidal
- CNS neoplasm, demyelinization disease, degenerative neurological disorder, active CNS infection, or any progressive CNS disorder that may confound interpretation of study results
- History of seizure disorder, or EEG showing paroxysmal activity or head CT showing gross structural abnormality
- Acute systemic medical disorder
- Use of any psychotropic medications within 2 weeks prior to screen or 4 weeks prior to screen in the case of fluoxetine
- Current use of any herbal medication such as St. John's wort,
- Uncontrolled renal, hepatic, endocrine, cardiovascular, pulmonary, immunological, hematological or gastrointestinal disease
- Any other abnormal medical screening tests judged by the investigator to be clinically significant
- Received any experimental medication within 30 days prior to study entry
- Patients presently in or soon to be starting psychotherapy
- Prior treatment non-response to an adequate trial of citalopram, escitalopram, or sertraline
- History of allergy to citalopram, escitalopram or sertraline
Contacts and Locations| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Joshua Boverman, MD | Oregon Health and Science University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00234312 History of Changes |
| Other Study ID Numbers: | 04-2801-A 02 |
| Study First Received: | October 4, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Depressive Disorders |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Citalopram Sertraline Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 23, 2013