Traumatic Brain InjuryPhase 2DuloxetineNCT01223001
Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
A Phase 2 study testing Duloxetine and Sugar pill in people with Traumatic Brain Injury and Depression, run by Rehabilitation Hospital of Indiana at 1 site in United States.
Trial summary
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, Depression
- What is being tested?
- Duloxetine and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Jul 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants will be 40 men and women between the ages of 18 and 75 who provide appropriate consent and who are agreeable to study requirements
- Diagnosed with mild to moderate traumatic brain injury as defined by an initial Mayo Traumatic Brain Injury Severity Scale
- Have memory impairments defined by a Hopkins Verbal Learning Test delayed recall score which falls less than or equal to 1.5 standard deviation below the mean.
Who cannot join
- Refusal to give informed consent
- A previous Central Nervous System illness or injury, including seizure that exhibits residual symptoms.
- Current post-traumatic seizure disorder
- A previous diagnosis of a psychotic disorder
- Current or previous (in the last 6 months) treatment history for alcohol or substance dependency
- Medications affecting noradrenergic or dopaminergic systems, alpha-adrenergic antihypertensives, antidepressant, phenobarbital, Monoamine oxidase inhibitor (MAOI), scheduled benzodiazepines, psychoactive herbal supplements (including Kava, St. John's wort), or nutritional supplements or within at least 14 days of discontinuing treatment with the above medications or supplements.
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- A known suicide risk
- A pregnant or breastfeeding woman
- Uncontrolled narrow-angle glaucoma
- Serious and/or unstable medical comorbidity (e.g., AIDS, cancer, history of uncontrolled hypertension or cardiovascular disease) psychological condition, or clinically significant laboratory abnormality that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study
- Liver enzymes > 1.5 times upper limit of normal
- Patients with end-stage renal disease (requiring dialysis) or severe renal impairment
- Known hypersensitivity to duloxetine or any of the inactive ingredients
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
Official title: Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.
Read the detailed description
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression.
- Conditions
- Traumatic Brain Injury, Depression
- Being tested
- Duloxetine, Sugar pill
- Keywords
- Depression, Traumatic brain injury, Duloxetine, Cymbalta, impaired cognitive function
- Medical subject headings
- Brain Injuries, Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
Sugar pillDrug
Also called Lactose
Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Active comparator | Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. Receives: Drug: Duloxetine |
| Sugar pill | Placebo comparator | Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.
Measured: 9 months
Secondary outcomes (1)
Hopkins Verbal Learning Test
To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 1996
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Most potential subjects had already been prescribed Cymbalta.
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 Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Indiana
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Lance Trexler, Ph.D., Principal investigator, Rehabilitation Hospital of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223001
- Sponsor's protocol ID
- RHI 05-096
- Other IDs
- F1J-US-X025
- Acronym
- Duloxetine
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2010
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine
- ClinicalTrials.gov ID
- NCT01223001
- Acronym / sponsor ID
- Duloxetine / RHI 05-096
- Conditions
- Traumatic Brain Injury, Depression
- Keywords
- Depression, Traumatic brain injury, Duloxetine, Cymbalta, impaired cognitive function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Most potential subjects had already been prescribed Cymbalta.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rehabilitation Hospital of IndianaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 1996
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 17 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.
Detailed description
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression.
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 |
|---|---|---|
| Duloxetine | Active comparator | Drug: DuloxetineDuloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. |
| Sugar pill | Placebo comparator | Drug: Sugar pillSugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study participants will be 40 men and women between the ages of 18 and 75 who provide appropriate consent and who are agreeable to study requirements
- Diagnosed with mild to moderate traumatic brain injury as defined by an initial Mayo Traumatic Brain Injury Severity Scale
- Have memory impairments defined by a Hopkins Verbal Learning Test delayed recall score which falls less than or equal to 1.5 standard deviation below the mean.
Key exclusion criteria (13 listed)
- Refusal to give informed consent
- A previous Central Nervous System illness or injury, including seizure that exhibits residual symptoms.
- Current post-traumatic seizure disorder
- A previous diagnosis of a psychotic disorder
- Current or previous (in the last 6 months) treatment history for alcohol or substance dependency
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaDuloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. | Drug | Duloxetine |
| Sugar pillAlso: LactoseSugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. | Drug | Sugar pill |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: 9 months
To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.
1 secondary outcome
Hopkins Verbal Learning Test
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Traumatic Brain Injury
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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.
Lance Trexler, Ph.D. principal investigator
Rehabilitation Hospital of Indiana
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 Duloxetine and Sugar pill in people with Traumatic Brain Injury and Depression, run by Rehabilitation Hospital of Indiana 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Dec 2014. 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 17 Dec 2014). 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?
Hamilton Rating Scale for Depression (time frame: 9 months). 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 17 Dec 2014.