Dysthymic DisorderPhase 4NCT00220701
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
A Phase 4 study testing Lexapro (escitalopram) in people with Dysthymic Disorder, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysthymic Disorder
- What is being tested?
- Lexapro (escitalopram)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients 18-65 years of age.
- Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.
- Subject must be considered reliable.
- Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.
Who cannot join
- Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
- Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.
- Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).
- Patients with a principal diagnosis meeting DSM-IV criteria for:
- Major Depressive Disorder, current
- Bipolar Disorder or cyclothymia .Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified.
Show all 18Show fewer
- Anorexia Nervosa or Bulimia
- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.
- Patients who have taken psychotropic medication or herbal preparations with putative psychotropic effects within 7 days prior to Visit 2. Patients taking a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) must have a washout period of 14 days prior to visit 2, and patients taking fluoxetine must have a washout period of at least 4 weeks prior to Visit 2.
- Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
- Report of having a specific plan for killing themselves
- A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors)
- A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication.
- Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic o neurologic disease, or any clinically significant laboratory abnormality.
- Patients who lack the capacity to proved informed consent
- 50% or greater decrease in HDRS total score from visit 2 to visit 3 or a CGI-Improvement score of 1 ("very much improved") or 2 ("much improved") at Visit 3
- Patients receiving CGI Improvement scores of 6 ("much worse") or 7 ("very much worse") for two consecutive visits will be withdrawn from the study.
- Patients who meet criteria for Major Depressive Disorder at any time during the course of the study will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York, New York, 10019
About this study
Official title: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.
Read the detailed description
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.
- Conditions
- Dysthymic Disorder
- Being tested
- Lexapro (escitalopram)
- Keywords
- Dysthymic Disorder, Depression, Chronic Depression, Escitalopram
- Medical subject headings
- Dysthymic Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lexapro (escitalopram)Drug
Also called lexapro, escitalopram, s-citalopram, d-citalopram
antidepressant drug selective serotonin reuptake inhibitor (SSRI)
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Experimental | Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. Receives: Drug: Lexapro (escitalopram) |
| Placebo | Placebo comparator | inactive comparator Receives: Drug: Lexapro (escitalopram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Measured: Week 12
Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Measured: Baseline
Secondary outcomes (4)
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Measured: Week 12
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Measured: Baseline
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Measured: Baseline
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysthymic DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- David J. Hellerstein, MD, Principal investigator, St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220701
- Sponsor's protocol ID
- LXP-MD-34
- Status last verified
- Nov 2007
- First submitted
- 21 Sep 2005
- Last updated
- 11 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8. doi: 10.1097/YIC.0b013e328333c35e.
PubMed 21811192
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
- ClinicalTrials.gov ID
- NCT00220701
- Acronym / sponsor ID
- LXP-MD-34
- Conditions
- Dysthymic Disorder
- Keywords
- Dysthymic Disorder, Depression, Chronic Depression, Escitalopram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jun 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 25 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.
Detailed description
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: Lexapro (escitalopram)Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day. |
| Placebo | Placebo comparator | Drug: Lexapro (escitalopram)inactive comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female outpatients 18-65 years of age.
- Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.
- Subject must be considered reliable.
- Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.
Key exclusion criteria (18 listed)
- Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
- Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.
- Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).
- Patients with a principal diagnosis meeting DSM-IV criteria for:
- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.
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 |
|---|---|---|
| Lexapro (escitalopram)Also: lexapro, escitalopram, s-citalopram, d-citalopramantidepressant drug selective serotonin reuptake inhibitor (SSRI) | Drug | Placebo, escitalopram |
Primary outcome
Hamilton-Depression Rating Scale (HDRS-24 Items)
Time frame: Week 12
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Hamilton-Depression Rating Scale (HDRS-24 Items)
Time frame: Baseline
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
4 secondary outcomes
Clinical Global Impressions - Severity (CGI-S)
Time frame: Week 12
Beck Depression Inventory (BDI)
Time frame: Baseline
Clinical Global Impressions - Severity (CGI-S)
Time frame: Baseline
Beck Depression Inventory (BDI)
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21811192Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8. doi: 10.1097/YIC.0b013e328333c35e.
- For more information about our program and this study click here.Link provided by the sponsor.
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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.
David J. Hellerstein, MD principal investigator
St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute
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 Lexapro (escitalopram) in people with Dysthymic Disorder, run by St. Luke's-Roosevelt Hospital Center 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 4 inclusion and 18 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 11 Nov 2015. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hamilton-Depression Rating Scale (HDRS-24 Items) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00220701, which also lists 1 linked publication.
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 11 Nov 2015.