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Trial record 49 of 590 for:    ESCITALOPRAM AND Celexa

Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

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ClinicalTrials.gov Identifier: NCT00220701
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 25, 2014
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dysthymic Disorder
Intervention Drug: Lexapro (escitalopram)
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Placebo
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Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Period Title: Overall Study
Started 17 17
Completed 12 13
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             5             4
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
43.88  (9.92) 43.59  (11.33) 43.74  (10.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
6
  35.3%
11
  64.7%
17
  50.0%
Male
11
  64.7%
6
  35.3%
17
  50.0%
1.Primary Outcome
Title Hamilton-Depression Rating Scale (HDRS-24 Items)
Hide Description 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)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
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Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.88  (5.83) 16.41  (6.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter F statistics
Estimated Value 2.82
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hamilton-Depression Rating Scale (HDRS-24 Items)
Hide Description 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)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.82  (5.75) 24.41  (6.25)
3.Secondary Outcome
Title Clinical Global Impressions - Severity (CGI-S)
Hide Description Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.35  (0.93) 3.41  (1.06)
4.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.00  (5.21) 16.25  (5.12)
5.Secondary Outcome
Title Clinical Global Impressions - Severity (CGI-S)
Hide Description Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.06  (0.24) 4.06  (0.43)
6.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.76  (4.91) 10.00  (5.16)
Time Frame Participants were evaluated weekly for the first two weeks after randomization and then biweekly thereafter till week 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description

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

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/17 (88.24%)      14/15 (93.33%)    
Gastrointestinal disorders     
Upset stomach *  0/17 (0.00%)  0 3/15 (20.00%)  3
General disorders     
Other *  3/17 (17.65%)  3 10/15 (66.67%)  10
Nervous system disorders     
Lightheadedness *  3/17 (17.65%)  3 0/15 (0.00%)  0
Reproductive system and breast disorders     
Decreased Libido *  6/17 (35.29%)  6 1/15 (6.67%)  1
Delayed Ejection *  3/17 (17.65%)  3 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Small double blinded study with limited power.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Hellerstein MD
Organization: NY State Psychiatric Institute
Phone: 6467748000
EMail: hellers@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220701     History of Changes
Other Study ID Numbers: LXP-MD-34
First Submitted: September 21, 2005
First Posted: September 22, 2005
Results First Submitted: November 19, 2014
Results First Posted: November 25, 2014
Last Update Posted: November 11, 2015