CompletedNot Applicable

Combined Antidepressant and Behavioural Intervention

United Kingdom134 participantsStarted 2021-05-28

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18-65 years inclusive * Resident in the UK for the duration of the study * Fluent in English * Normal or corrected-to-normal vision * Experiencing subjective low mood (score of 10 or above on the BDI-II) * Experiencing low activity levels (self-reported) * Willing and able to give informed consent for participation in the research * Access to a computer or laptop with a functioning keyboard and a reliable internet connection Exclusion Criteria: * Antidepressant treatment or medication prescribed to treat depression/low mood, currently or in the last six months * Current psychological therapy of any kind * Current or past probable diagnosis of psychosis, bipolar disorder, OCD, PTSD, substance abuse disorder or any eating disorder, as indicated by the SCID-5 * Current or past diagnosis of any personality disorder (e.g. borderline personality disorder) according to self-report * Judged to be at clinical high risk of suicide * Past suicide attempt * Current or past hospitalisation for mental health reasons * 1st degree relative with diagnosis of bipolar disorder * Diagnosis of a developmental disorder (e.g. ASD, ADHD, Tourette's syndrome, severe learning disability) according to self-report; this excludes cases of mild dyslexia or dyscalculia where in the opinion of the study team such difficulties would not interfere with the performance of the tasks required in this study * Diagnosis of a neurological disorder (e.g. epilepsy, MS) according to self-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in emotional cognition

Timeframe: Pre-intervention and 13-15 days after the start of the intervention

Trial details

NCT IDNCT05627154

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-17

View on ClinicalTrials.gov More Low Mood trials