Depression Clinical Trial
Official 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
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).
Depression is common in adolescence and is associated with a high risk of suicide.
Clinically, the presentation of depression in young people is largely similar to the symptoms
seen in adulthood, although depressed youth may exhibit increased irritability rather than
(or in addition to) low mood. Therefore, irritability is included as a cardinal symptom in
the diagnosis of Major Depressive Disorder (MDD) among children and adolescents but not
adults (American Psychiatric Association, 2013).
Fluoxetine is the antidepressant with the most favourable benefit:risk ratio profile to treat
adolescent depression, and is the only medication approved for use to treat this disorder in
the United Kingdom (UK). In the United States (US), fluoxetine is also the drug of choice,
together with escitalopram. However, our current understanding of the mechanisms underlying
antidepressant action in adolescents and young people is poor, despite the pressing need to
explain the complex patterns of clinical response to pharmacotherapy in this group.
In this randomised, placebo-controlled experimental medicine study, the investigators propose
to use fMRI to investigate the early effects of fluoxetine in a sample of depressed
adolescents who have been prescribed fluoxetine by their psychiatrist for the treatment of
depression. Immediately after being referred to the study team, participants will be
randomised to take their first dose of either fluoxetine or placebo within the study, and 6
hours later, they will undergo a neuroimaging scan.
Previous research from our group showed that a single dose of fluoxetine reduced the accuracy
to detect angry facial expressions in a group of young healthy volunteers, aged 18 to 21
(Capitão et al., 2015). Given the key role of anger in the clinical presentation of
adolescent depression, the reduction in anger perception following fluoxetine highlights a
potential mechanism through which this antidepressant drug may exert its clinical action.
However, this hypothesis remains to be investigated in depressed adolescents.
This study therefore proposes to investigate the acute effects of fluoxetine vs. placebo on
emotional neural processing, specifically in response to angry faces, in a sample of
adolescents with MDD. A secondary aim is to investigate the effects of fluoxetine on
emotional regulation, as well as on resting-state functional connectivity.
To the extent of the investigators' knowledge, this is the first study to explore the acute
neural effects of fluoxetine in depressed adolescents. This design is thought to be of high
value as patients will be referred to the study immediately after being prescribed
fluoxetine, therefore allowing the investigators to scan them on the day that they take their
first dose of 10 mg fluoxetine or placebo, administered within the study. Patients will then
start their antidepressant treatment as prescribed and managed by their treating
psychiatrist. This unique time window for testing allows the investigation of the effects of
fluoxetine using a placebo control, and without the ethical concerns associated with
long-term antidepressant drug studies. This single dose design also enables the
characterisation of the effects of fluoxetine at a time where changes in mood are not yet
apparent. Indeed, the few neuroimaging studies conducted to date with depressed adolescents
are limited by the absence of a placebo control and the measurement of neural changes after
relatively prolonged treatments (8 weeks). Concurrent changes in symptoms make it difficult
to determine whether fluoxetine has a direct effect on relevant neural regions or whether the
antidepressant-induced changes in activity are an indirect consequence of mood improvement.
The current study design overcomes these constraints.
The knowledge attained from this study will hopefully help increase our understanding of the
early mechanisms underlying fluoxetine use in depressed adolescents.
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