- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00254007
Depression and Traumatic Brain Injury
The Serotonin Transporter Gene Polymorphism and Major Depression Following Traumatic Brain Injury
Problem: Depressive symptoms are a common mental health problem following traumatic brain injury (TBI), occurring in up to 87% of patients. Depression following TBI has important consequences including poor functioning, lack of ability to return to work and family activities and prolonged TBI symptoms. The reason depression develops in some patients following TBI is unknown, making treatment difficult.
One type of brain protein that shows genetic differences between people is called the serotonin transporter. People can be divided by whether or not they have a short protein (S allele) or a long protein (L allele) which influences the amount of serotonin transporter. Serotonin is a key brain chemical in depression in many mental/psychiatric illnesses. We think that the genetic differences in the serotonin transporter, that may not make a difference before TBI, may become important after TBI due to the nature of these injuries.
Methods: A consecutive sample of 200 patients attending a TBI clinic who have sustained a mild-to-moderate TBI (American Congress of Rehabilitation Medicine criteria) within the last 2 months will be assessed for the presence of major depression (standard criteria, standardized interview). In phase I, blood samples from patients with mild-to-moderate TBI with depression and without depression will be checked for the presence of the 5-HTTPR genetic difference. This will allow us to study if the S allele is more likely in TBI patients with depression. In phase II, the patients with depression will be treated with the SSRI citalopram for 6 weeks. At 6 weeks, or upon discontinuation of citalopram, depression will be assessed again. This will allow us to study if depressed patients with the S allele respond more poorly to treatment. Persons assessing depression after treatment will not know the genetic makeup of each patient.
Results Expected: If the serotonin transporter genetic difference confers susceptibility to depression following TBI, this will provide important information on what causes depression following TBI and document a risk factor for depression previously unstudied in this population. Also, as SSRI antidepressants are used to treat depression in TBI, this study may identify a subgroup of TBI patients in whom different medications should be given or additional medications are required.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age >18 years
- gender: male or female
- TBI within the last two months
- mild to moderate TBI
- written, informed consent
- depressed group only: diagnosis of major depressive episode using the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)
Exclusion Criteria:
- prior TBI or other focal brain disease (stroke, tumor)
- significant acute medical illness, including: drug overdose, severely disturbed liver, kidney, lung, or heart function, anemia, hypothyroidism, uncontrolled diabetes, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis
- a brain CT scan revealing focal lesions that could not be interpreted as consistent with a TBI
- depression group only: contraindications to receiving treatment with citalopram
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Hamilton Depression Rating Scale (HAM-D)
Time Frame: Baseline, 6 weeks and 10 weeks (if applicable)
|
Baseline, 6 weeks and 10 weeks (if applicable)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory (BDI), Rivermead Head Injury Follow-up Questionnaire (RHFQ), General Health Questionnaire (GHQ), Rivermead Post Concussion Disorder Questionnaire (RPDQ)
Time Frame: Baseline, 6 weeks and 10 weeks (if applicable)
|
Baseline, 6 weeks and 10 weeks (if applicable)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Krista L Lanctôt, PhD, Sunnybrook Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Depression
- Depressive Disorder
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 205-2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on citalopram (celexa)
-
Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Mclean HospitalCompletedMajor Depressive Disorder | MDD | CitalopramUnited States
-
Ontario Neurotrauma FoundationUnknown
-
JHSPH Center for Clinical TrialsNational Institute of Mental Health (NIMH); National Institute on Aging (NIA)CompletedAlzheimer's Disease | AgitationUnited States, Canada
-
Veterans Medical Research FoundationNational Institute of Mental Health (NIMH)Completed
-
University of IowaMayo Clinic; National Institute of Neurological Disorders and Stroke (NINDS); University of Rochester and other collaboratorsCompletedHuntington Disease | Chorea | Executive DysfunctionUnited States
-
New York State Psychiatric InstituteNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedMajor Depressive Disorder | Alcohol Use DisorderUnited States
-
University of CincinnatiNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcoholism | Alcohol AbuseUnited States
-
Sunnybrook Health Sciences CentreCompleted
-
Bruce PollockNational Institute of Mental Health (NIMH)CompletedDementia | Alzheimer Disease | Dementia, VascularUnited States