DepressionPhase 4NCT00234312
Medications for the Treatment of Dysthymic Disorder and Double Depression
A Phase 4 study testing escitalopram and sertraline in people with Depression and Dysthymia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Dysthymia
- What is being tested?
- escitalopram and sertraline
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
Official title: Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
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.
Read the detailed description
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.
- Conditions
- Depression, Dysthymia
- Being tested
- escitalopram and sertraline
- Keywords
- Depressive Disorders
- Medical subject headings
- Depression, Dysthymic Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram and sertralineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
score on first 17 items of HAM-D Rating Scale 24 item, each visit
Secondary outcomes (1)
scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Joshua Boverman, MD, Oregon Health and Science University
- Investigators
- Joshua Boverman, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234312
- Sponsor's protocol ID
- 04-2801-A 02
- Status last verified
- Jul 2019
- First submitted
- 4 Oct 2005
- Last updated
- 29 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression
- ClinicalTrials.gov ID
- NCT00234312
- Acronym / sponsor ID
- 04-2801-A 02
- Conditions
- Depression, Dysthymia
- Keywords
- Depressive Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Sep 2005 (actual)
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopram and sertraline | Drug | – |
Primary outcome
score on first 17 items of HAM-D Rating Scale 24 item, each visit
1 secondary outcome
scores on HAM-D 21, HAM-D 24, and Beck Depression Inventory (pt. rated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Boverman, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram and sertraline in people with Depression and Dysthymia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score on first 17 items of HAM-D Rating Scale 24 item, each visit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.