NCT00220701

Brief 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. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

November 25, 2014

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2007

Enrollment Period

6.4 years

First QC Date

September 21, 2005

Results QC Date

November 19, 2014

Last Update Submit

October 13, 2015

Conditions

Dysthymic Disorder

Keywords

Dysthymic DisorderDepressionChronic DepressionEscitalopram

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    Baseline

Secondary Outcomes (4)

  • Clinical Global Impressions - Severity (CGI-S)

    Week 12

  • Beck Depression Inventory (BDI)

    Baseline

  • Clinical Global Impressions - Severity (CGI-S)

    Baseline

  • Beck Depression Inventory (BDI)

    Week 12

Study Arms (2)

escitalopram

EXPERIMENTAL

Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

Drug: Lexapro (escitalopram)

Placebo

PLACEBO COMPARATOR

inactive comparator

Drug: Lexapro (escitalopram)

Interventions

Lexapro (escitalopram)DRUG

antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Also known as: lexapro, escitalopram, s-citalopram, d-citalopram
Placeboescitalopram

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Related Publications (1)

  • 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.

    PMID: 21811192RESULT

Related Links

MeSH Terms

Conditions

Dysthymic DisorderDepression

Interventions

EscitalopramDexetimide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidonesPiperidinesHeterocyclic Compounds, 1-Ring

Limitations and Caveats

Small double blinded study with limited power.

Results Point of Contact

Title
David Hellerstein MD
Organization
NY State Psychiatric Institute
hellers@nyspi.columbia.edu
6467748000

Study Officials

  • David J. Hellerstein, MD

    St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 22, 2005

Study Start

June 1, 2002

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

November 11, 2015

Results First Posted

November 25, 2014

Record last verified: 2007-11

Locations

US(1)