Combined Antidepressant and Behavioural Intervention

NCT05627154 | Completed

• 1 other identifier: Cabin
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Mood; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Changes in emotional cognition

  Accuracy and reaction times on computer-based measures of emotional cognition (facial expression recognition task, emotional word categorisation task, emotional word recall task, emotional word recognition task).

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

Secondary Outcomes (3)

• Changes in reward processing

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

• Changes in motor activity

  7 days pre-intervention compared to last 7 days of intervention

• Changes in salivary cortisol

  Pre-intervention and 13-14 days after the start of the intervention

Other Outcomes (1)

• Changes in daily mood

  7 days pre-intervention compared to last 7 days of intervention

Study Arms (3)

Placebo only

PLACEBO COMPARATOR

Participants randomised to the Placebo condition will be taking a lactose placebo capsule daily for 14 days.

Drug: Placebo

Citalopram only

EXPERIMENTAL

Participants randomised to the Citalopram only condition will be taking 20mg of citalopram in capsule form daily for 14 days.

Drug: Citalopram

Citalopram and Behavioural Activation

EXPERIMENTAL

Participants randomised to the Citalopram only condition will be taking 20mg of citalopram in capsule form daily for 14 days. Over the two weeks of taking citalopram, they will also receive \~3h of behavioural activation therapy split into 3 sessions.

Drug: Citalopram; Behavioral: Behavioural Activation

Interventions

Citalopram DRUG

Serotonin-reuptake inhibitor commonly used to treat depressive and anxiety disorders.

Citalopram and Behavioural Activation; Citalopram only

Behavioural Activation BEHAVIORAL

A NICE recommended psychological intervention for mild to moderate depression. In behavioural activation, the person with depression and the therapist work together to identify the relationships between the activities the person undertakes and their mood. It encourages people to become less mood-dependent when planning activities and doing constructive things that they would usually avoid doing.

Citalopram and Behavioural Activation

Placebo DRUG

A lactose-based tablet.

Placebo only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• st 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-report
• Score of \>30 on the BDI-II
• Current use of medication that might interact with the effects of citalopram (except for the contraceptive pill)
• Known contraindication to citalopram including: past allergic reaction to citalopram or any other medicines, diagnosis of a cardiovascular condition, glaucoma, type 1 or type 2 diabetes, diagnosis of epilepsy, undergoing electroconvulsive treatment (ECT), or current use of any other medication that is associated with prolonged QT-interval
• Any other current or past medical conditions which in the opinion of the study medic may interfere with the safety of the participant or the scientific integrity of the study
• Heavy use of cigarettes (smoke \> 20 cigarettes per day)

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Neurosciences Building, Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Consciousness Disorders; Depression; Anxiety Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Catherine J Harmer, DPhil

  Department of Psychiatry, University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, the study will be single blinded only to citalopram or placebo administration. As the primary researcher will be the one administering the behavioural activation (BA) training, both the participants and the primary researcher will be aware of who did or did not receive the psychological intervention. However, participants will not be aware that receiving BA means they are also taking citalopram. The primary researcher, on the other hand, will be aware of this and will only be blinded to drug administration in the BA-free groups. To compensate for the lack of complete blinding, post-treatment outcome data will be collected online and not directly by the primary researcher. Moreover, before the data is analysed, participant ID numbers will be re-allocated to avoid bias in the outlier detection and data exclusion process.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomised into one of three groups, each undergoing two weeks of either: 1) placebo alone, 2) citalopram alone or 3) citalopram and behavioural activation training.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: November 25, 2022
• Study Start: May 28, 2021
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

GB (1)