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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01368432
First received: June 3, 2011
Last updated: August 31, 2016
Last verified: August 2016
Results First Received: July 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: TBI
Major Depression
Other Psychiatric Disorders
Interventions: Drug: Escitalopram
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
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.

Participant Flow:   Overall Study
    Placebo   Escitalopram
STARTED   6   8 
COMPLETED   6   7 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
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 Total of all reporting groups

Baseline Measures
   Placebo   Escitalopram   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   8   14 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   5   7   12 
>=65 years   1   1   2 
Gender 
[Units: Participants]
     
Female   3   2   5 
Male   3   6   9 
Region of Enrollment 
[Units: Participants]
     
United States   6   8   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline   [ Time Frame: MADRS score at baseline ]

2.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: MADRS score at 12 weeks ]

3.  Secondary:   Clinical Global Impression (CGI) - Severity at Baseline   [ Time Frame: Baseline ]

4.  Secondary:   Clinical Global Impression (CGI)- Improvement   [ Time Frame: at 12 weeks ]

5.  Secondary:   Clinical Anxiety Scale (CAS)   [ Time Frame: Baseline ]

6.  Secondary:   Clinical Anxiety Scale (CAS)   [ Time Frame: 12 weeks ]

7.  Secondary:   Satisfaction With Life (SWL)   [ Time Frame: baseline ]

8.  Secondary:   Satisfaction With Life (SWL)   [ Time Frame: 12 weeks ]

9.  Secondary:   Quality of Life (QWL)   [ Time Frame: At baseline ]

10.  Secondary:   Quality of Life (QWL)   [ Time Frame: At 12 weeks ]

11.  Secondary:   Disability Rating Scale (DRS)   [ Time Frame: At baseline ]

12.  Secondary:   Disability Rating Scale (DRS)   [ Time Frame: At 12 weeks ]

13.  Secondary:   Mini Mental Status Exam (MMSE)   [ Time Frame: At baseline ]

14.  Secondary:   Mini Mental Status Exam (MMSE)   [ Time Frame: At 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: vrao@jhmi.edu



Responsible Party: Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01368432     History of Changes
Other Study ID Numbers: NA_00020154
Study First Received: June 3, 2011
Results First Received: July 13, 2016
Last Updated: August 31, 2016
Health Authority: United States: Institutional Review Board