Low MoodCABINNCT05627154
Combined Antidepressant and Behavioural Intervention
A study testing Citalopram and Behavioural Activation in people with Low Mood and Depression, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Mood, Depression, Anxiety
- What is being tested?
- Citalopram and Behavioural Activation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 May 2021to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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-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)
- Heavy use of caffeine (drink > 4 250ml cups/cans of coffee/energy drinks per day)
- Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medic
- Lactose intolerance (due to the study involving administration of a lactose placebo tablet)
- Pregnancy (as determined by urine pregnancy test taken during the Part 2 screening visit), breast feeding or plans to become pregnant
- Participation in an ETB study in the past 6 months
- Participation in another drug study in the past 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neurosciences Building, Warneford Hospital
Oxford, Oxfordshire, OX3 7JX
About this study
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.
Read the detailed description
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.
- Conditions
- Low Mood, Depression, Anxiety
- Being tested
- Citalopram, Behavioural Activation, Placebo
- Medical subject headings
- Consciousness Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Serotonin-reuptake inhibitor commonly used to treat depressive and anxiety disorders.
Behavioural ActivationBehavioural
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.
PlaceboDrug
A lactose-based tablet.
| Study group | Role | What they receive |
|---|---|---|
| Placebo only | Placebo comparator | Participants randomised to the Placebo condition will be taking a lactose placebo capsule daily for 14 days. Receives: 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. Receives: 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. Receives: Drug: Citalopram; Behavioral: Behavioural Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre-intervention and 13-15 days after the start of the intervention
Secondary outcomes (3)
Changes in reward processing
Accuracy, consistency, reaction times, monetary wins and losses, learning rate and decision temperature on the Probabilistic Instrumental Learning Task.
Measured: Pre-intervention and 13-15 days after the start of the intervention
Changes in motor activity
Acceleration, light and temperature data measured at 25 Hz using GENEActiv actigraphy watches
Measured: 7 days pre-intervention compared to last 7 days of intervention
Changes in salivary cortisol
Waking cortisol levels assayed using a Salimetrics Salivary Cortisol ELISA Kit from 6 saliva samples (3 pre- and 3 post-intervention) collected using Sarstedt Salivette® Cortisol tubes
Measured: Pre-intervention and 13-14 days after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start28 May 2021
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low MoodStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Catherine J Harmer, DPhil, Principal investigator, Department of Psychiatry, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627154
- Sponsor's protocol ID
- Cabin
- Acronym
- CABIN
- Status last verified
- May 2024
- First submitted
- 31 May 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 14-day Combined Antidepressant and Behavioural Intervention on Emotional Cognition in Healthy Volunteers Experiencing Low Mood
- ClinicalTrials.gov ID
- NCT05627154
- Acronym / sponsor ID
- CABIN / Cabin
- Conditions
- Low Mood, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 28 May 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo only | Placebo comparator | Drug: PlaceboParticipants randomised to the Placebo condition will be taking a lactose placebo capsule daily for 14 days. |
| Citalopram only | Experimental | Drug: CitalopramParticipants randomised to the Citalopram only condition will be taking 20mg of citalopram in capsule form daily for 14 days. |
| Citalopram and Behavioural Activation | Experimental | Drug: Citalopram, Behavioral: Behavioural ActivationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramSerotonin-reuptake inhibitor commonly used to treat depressive and anxiety disorders. | Drug | Citalopram and Behavioural Activation, Citalopram only |
| Behavioural ActivationA 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. | Behavioural | Citalopram and Behavioural Activation |
| PlaceboA lactose-based tablet. | Drug | Placebo only |
Primary outcome
Changes in emotional cognition
Time frame: Pre-intervention and 13-15 days after the start of the intervention
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).
3 secondary outcomes
Changes in reward processing
Time frame: Pre-intervention and 13-15 days after the start of the intervention
Changes in motor activity
Time frame: 7 days pre-intervention compared to last 7 days of intervention
Changes in salivary cortisol
Time frame: Pre-intervention and 13-14 days after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine J Harmer, DPhil principal investigator
Department of Psychiatry, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram and Behavioural Activation in people with Low Mood and Depression, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in emotional cognition (time frame: Pre-intervention and 13-15 days after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.