TBIPhase 2NCT01368432
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
A Phase 2 study testing Escitalopram in people with TBI and Major Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI, Major Depression, Other Psychiatric Disorders
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Closed head injury
- Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"
- 18 years of age or older
- Able to provide informed consent
- Stable medical history
Who cannot join
- History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
- History of mental retardation
- Alcohol or Substance dependence in the last 1 year
- Inability to undergo MRI scan
- Pregnancy
- Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics
Show all 9Show fewer
- Poor response to escitalopram in the past
- Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist
- Good medication response to another antidepressant in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions
This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).
Read the detailed description
Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.
- Conditions
- TBI, Major Depression, Other Psychiatric Disorders
- Being tested
- Escitalopram, Placebo
- Keywords
- TBI, Depression, Mood, Behavior
- Medical subject headings
- Depressive Disorder, Major, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
PlaceboDrug
Also called sugar pill
Sugar pill placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily for 12 weeks Receives: Drug: Placebo |
| Escitalopram | Experimental | Escitalopram 10 mg or 20 mg daily for 12 weeks Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
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.
Measured: MADRS score at baseline
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Measured: MADRS score at 12 weeks
Secondary outcomes (12)
Clinical Global Impression (CGI) - Severity at Baseline
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
- = Normal-not at all ill
- = Borderline mentally ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Among the most extremely ill patients.
Measured: Baseline
Clinical Global Impression (CGI)- Improvement
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
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
Measured: at 12 weeks
Clinical Anxiety Scale (CAS)
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.
Measured: Baseline
Clinical Anxiety Scale (CAS)
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.
Measured: 12 weeks
Satisfaction With Life (SWL)
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.
Measured: baseline
Satisfaction With Life (SWL)
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.
Measured: 12 weeks
Quality of Life (QWL)
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.
Measured: At baseline
Quality of Life (QWL)
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.
Measured: At 12 weeks
Disability Rating Scale (DRS)
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).
Measured: At baseline
Disability Rating Scale (DRS)
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).
Measured: At 12 weeks
Mini Mental Status Exam (MMSE)
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.
Measured: At baseline
Mini Mental Status Exam (MMSE)
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.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionMar 2013
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.
- Other trials for TBIStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Vani Rao, MD, Johns Hopkins University
- Investigators
- Vani Rao, M.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368432
- Sponsor's protocol ID
- NA_00020154
- Status last verified
- Aug 2016
- First submitted
- 3 Jun 2011
- Last updated
- 24 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions
- ClinicalTrials.gov ID
- NCT01368432
- Acronym / sponsor ID
- NA_00020154
- Conditions
- TBI, Major Depression, Other Psychiatric Disorders
- Keywords
- TBI, Depression, Mood, Behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Posted 24 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).
Detailed description
Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDaily for 12 weeks |
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram 10 mg or 20 mg daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Closed head injury
- Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"
- 18 years of age or older
- Able to provide informed consent
- Stable medical history
Key exclusion criteria (9 listed)
- History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
- History of mental retardation
- Alcohol or Substance dependence in the last 1 year
- Inability to undergo MRI scan
- Pregnancy
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 |
|---|---|---|
| EscitalopramAlso: LexaproEscitalopram 10 mg or 20 mg daily for 12 weeks by mouth | Drug | Escitalopram |
| PlaceboAlso: sugar pillSugar pill placebo | Drug | Placebo |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
Time frame: MADRS score at baseline
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.
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: MADRS score at 12 weeks
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.
12 secondary outcomes
Clinical Global Impression (CGI) - Severity at Baseline
Time frame: Baseline
Clinical Global Impression (CGI)- Improvement
Time frame: at 12 weeks
Clinical Anxiety Scale (CAS)
Time frame: Baseline
Clinical Anxiety Scale (CAS)
Time frame: 12 weeks
Satisfaction With Life (SWL)
Time frame: baseline
Satisfaction With Life (SWL)
Time frame: 12 weeks
Quality of Life (QWL)
Time frame: At baseline
Quality of Life (QWL)
Time frame: At 12 weeks
Disability Rating Scale (DRS)
Time frame: At baseline
Disability Rating Scale (DRS)
Time frame: At 12 weeks
Mini Mental Status Exam (MMSE)
Time frame: At baseline
Mini Mental Status Exam (MMSE)
Time frame: At 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Brain Injury Association of MarylandLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vani Rao, M.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram in people with TBI and Major Depression, run by Johns Hopkins University 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 5 inclusion and 9 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 24 Oct 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Oct 2016). 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?
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline (time frame: MADRS score at baseline). 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?
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 24 Oct 2016.