Depression Clinical Trial
— OxSYPanOfficial title:
Investigating the Effects of the Antidepressant Fluoxetine on the Emotional Processing of Young People With Depression - a Double Blind, Placebo-controlled Design fMRI Study
Verified date | February 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fluoxetine is commonly used to treat adolescent depression, but the neural mechanisms underlying antidepressant drugs in the young brain are still poorly understood. This study proposes to investigate the effects of a single dose of fluoxetine on emotional neural processing in a sample of depressed adolescents, using functional Magnetic Resonance Imaging (fMRI).
Status | Completed |
Enrollment | 32 |
Est. completion date | November 10, 2015 |
Est. primary completion date | November 10, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Current episode of depression with or without comorbid anxiety and in need of antidepressant medication (as assessed by the Adolescent Psychiatrist); - Participant and parent/legal guardian (for participants younger than 16) are willing and able to give informed consent for participation in the study; - Male or female, aged 13-18; - Sufficiently fluent in English to understand the task and instructions. Exclusion Criteria: - Current or past psychosis or mania; - Current substance misuse; - Psychotropic medication usage within the past 6 weeks; - Contraindication to fMRI (e.g. metal in body, claustrophobia, pregnancy, etc); - Risk of waiting 5-7 days before the initiation of medication assessed as posing serious risk (as assessed by the Adolescent Psychiatrist). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Oxford |
American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders, 5th edn: DSM-5. American Psychiatric Association: Arlington, VA.
Capitão LP, Murphy SE, Browning M, Cowen PJ, Harmer CJ. Acute fluoxetine modulates emotional processing in young adult volunteers. Psychol Med. 2015 Aug;45(11):2295-308. doi: 10.1017/S0033291715000240. Epub 2015 Apr 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neural activity (BOLD response) in response to angry faces | fMRI data collected during a faces task involving angry, happy and fearful faces | 6 hours post-intervention | |
Secondary | Neural activity (BOLD response) in task measuring emotional regulation | fMRI data collected during an emotional regulation task | 6 hours post-intervention | |
Secondary | Resting-state functional connectivity | fMRI data collected during resting-state scan | 6 hours post-intervention |
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