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Trial record 47 of 585 for:    ESCITALOPRAM AND Celexa

Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01368432
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions TBI
Major Depression
Other Psychiatric Disorders
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 16
Recruitment Details Subjects were recruited from the Brain injury clinic at Johns Hopkins Bayview Medical Center, other Johns Hopkins outpatient clinics, and via advertisements in local papers.
Pre-assignment Details One admitted to active alcohol abuse before initiating medications , and therefore no longer met inclusion criteria. Another consented but failed to return for any follow-up visits.
Arm/Group Title Placebo Escitalopram
Hide Arm/Group Description The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Period Title: Overall Study
Started 6 8
Completed 6 7
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Placebo Escitalopram Total
Hide Arm/Group Description The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8. Total of all reporting groups
Overall Number of Baseline Participants 6 8 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
7
  87.5%
12
  85.7%
>=65 years
1
  16.7%
1
  12.5%
2
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Female
3
  50.0%
2
  25.0%
5
  35.7%
Male
3
  50.0%
6
  75.0%
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 14 participants
6 8 14
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
Hide Description

This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.

0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.

In this study the score was used as a continuous variable.

Time Frame MADRS score at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.5  (3.9) 33.6  (6.9)
2.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description

This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.

0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.

In this study the score was used as a continuous variable.

Time Frame MADRS score at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group MADRS 12 Weeks Treatment Group MADRS 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.2  (9.5) 7  (5.7)
3.Secondary Outcome
Title Clinical Global Impression (CGI) - Severity at Baseline
Hide Description

This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7

  1. = Normal—not at all ill
  2. = Borderline mentally ill
  3. = Mildly ill
  4. = Moderately ill
  5. = Markedly ill
  6. = Severely ill
  7. = Among the most extremely ill patients.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention and represents their baseline global health.
This group consists of participants who received escitalopram and represents their baseline global health
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5  (0.5) 4.8  (0.5)
4.Secondary Outcome
Title Clinical Global Impression (CGI)- Improvement
Hide Description

This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.

The scores range from 1-7

  1. = Very much improved
  2. = Much improved
  3. = Minimally improved
  4. = No change
  5. = Minimally worse
  6. = Much worse
  7. = Very much worse
Time Frame at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
This group consists of participants who received escitalopram and represents their global health at 12 weeks.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (1.2) 2.1  (0.6)
5.Secondary Outcome
Title Clinical Anxiety Scale (CAS)
Hide Description

This outcome measure is assessing the participant's anxiety as assessed by the CAS.

The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention and represents their anxiety score.
This group consists of participants who received escitalopram intervention and represents their anxiety score.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.8  (3.8) 14.8  (6.7)
6.Secondary Outcome
Title Clinical Anxiety Scale (CAS)
Hide Description

This outcome measure is assessing the participant's anxiety as assessed by the CAS.

The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention and represents their anxiety score.
This group consists of participants who received escitalopram intervention and represents their anxiety score.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (4.3) 3.9  (5)
7.Secondary Outcome
Title Satisfaction With Life (SWL)
Hide Description

This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.

The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).

It is used as continuous variable.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.8  (7.7) 15.6  (9.3)
8.Secondary Outcome
Title Satisfaction With Life (SWL)
Hide Description

This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.

The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).

It is used as continuous variable.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.2  (9.2) 22.6  (5.7)
9.Secondary Outcome
Title Quality of Life (QWL)
Hide Description

This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.

Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.

Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.8  (22.3) 64.1  (24.6)
10.Secondary Outcome
Title Quality of Life (QWL)
Hide Description

This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.

Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.

Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.2  (30.3) 78.7  (17.3)
11.Secondary Outcome
Title Disability Rating Scale (DRS)
Hide Description

This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.

Scores range from 0 (normal) and 29 (extreme vegetative state).

Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (1.3) 1.4  (1.1)
12.Secondary Outcome
Title Disability Rating Scale (DRS)
Hide Description

This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.

Scores range from 0 (normal) and 29 (extreme vegetative state).

Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (1) 0.6  (0.3)
13.Secondary Outcome
Title Mini Mental Status Exam (MMSE)
Hide Description

This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).

A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.

Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Baseline Treatment Group Baseline
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.3  (1.6) 27.1  (1.03)
14.Secondary Outcome
Title Mini Mental Status Exam (MMSE)
Hide Description

This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).

A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.

Time Frame At 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group 12 Weeks Treatment Group 12 Weeks
Hide Arm/Group Description:
This group consists of participants who received the placebo intervention.
This group consists of participants who received escitalopram intervention.
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.7  (0.5) 29.0  (0.6)
Time Frame Through study completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Escitalopram
Hide Arm/Group Description The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
All-Cause Mortality
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/8 (0.00%) 
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
Name/Title: Vani Rao
Organization: Johns Hopkins University & school of Medicine
Phone: 410-550-2288
EMail: vrao@jhmi.edu
Responsible Party: Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01368432     History of Changes
Other Study ID Numbers: NA_00020154
First Submitted: June 3, 2011
First Posted: June 8, 2011
Results First Submitted: July 13, 2016
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016