Depression Clinical Trial
Official title:
Effects of a 14-day Combined Antidepressant and Behavioural Intervention on Emotional Cognition in Healthy Volunteers Experiencing Low Mood
A body of evidence from both animal and human research suggests that antidepressant drugs may induce early changes in emotional processing that interact with environmental factors to produce a later change in mood. This experimental medicine study will examine the effect of citalopram on emotional cognition under different environmental conditions (as manipulated by the presence or absence of behavioural activation training). Participants will be administered either citalopram or placebo over the course of two weeks. Citalopram will be taken either alone or in combination with behavioural activation training.
Major Depressive Disorder (MDD) is a common psychiatric condition characterised by pervasive low mood as well as changes in sleep, appetite and cognition. In the UK, it is estimated that 3 in 100 people meet criteria for MDD every week, costing the economy £20.2-23.8 billion every year in health service, lost earnings and lower productivity. A variety of pharmacological and psychological interventions for MDD are available. Selective serotonin reuptake inhibitors (SSRIs) are the first-choice medication for depression in the UK, as recommended by National Institute of Health and Care Excellence (NICE) guidelines. Whilst SSRIs have been demonstrated to be more effective than placebo, only about 50% of patients respond to their first-prescribed antidepressant. Understanding the mechanism through which SSRIs exert their antidepressant effect could explain why their effectiveness is not universal and allow for personalised treatments. Experimental medicine studies conducted over the last 15-20 years have shown that SSRIs have early effects on emotional cognition, and that these precede clinically significant changes in depressive symptomatology. For example, one week of treatment with citalopram was found to decrease recognition of negative facial expressions and increase the relative recall of positive vs negative words. The switch from implicit changes in cognitive bias to explicit changes in mood is thought to occur through interaction with the environment and re-learning of positive associations. Indeed, rodent studies suggest that SSRIs only induce a positive bias in memory when administered before learning and that SSRI-induced neuroplasticity only occurs in the presence of an positive/enriched environment. These findings imply that an enriched environment from which patients can derive positive and meaningful reinforcement may be important for antidepressant function. This hypothesis is indirectly supported by multiple reports of a positive correlation between antidepressant treatment outcome and patients' socioeconomic status as a proxy for environmental enrichment, but to our knowledge this has not been experimentally tested in humans. This experimental medicine study will explore whether the early cognitive effects of the SSRI citalopram are modulated by different levels of environmental enrichment. The presence/absence of environmental enrichment will be modulated through provision of two weeks of behavioural activation (BA) training to a third of our sample; BA is a psychological intervention aimed to increase levels of environmental reinforcement by monitoring and adjusting an individual's daily activities. By comparing the combined effects of citalopram and BA to those of citalopram alone and placebo alone on performance of emotional cognition tasks (Emotional Test Battery (ETB)), the investigators will test whether the early cognitive changes induced by antidepressants are increased in the context of a more rewarding environment. The investigators hypothesise that the participant group receiving citalopram and BA will show greater changes in emotional cognition in the expected direction (decrease in negative bias/increase in positive bias) compared to the citalopram alone and placebo alone groups after the two-week intervention. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |