Reinforcement-learning processes engaged by two established antidepressant treatments Mental and Behavioural Disorders
Conditions
Interventions
This trial examines the reinforcement-learning processes engaged by two established antidepressant treatments, escitalopram and bupropion, to improve treatment in the future. This is a mechanistic stu
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meeting diagnostic criteria for a DSM-5 Major Depressive Episode on the affective disorder sections of the Mini International Neuropsychiatric Interview (MINI) 2. Patient Health Questionnaire (PHQ-9) total score > = 10 3. Under the care of a GP in the UK 4. Aged 18 years and above 5. Able to provide informed consent to participate in the trial 6. Women of childbearing potential (WOCBP) must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until six weeks after treatment discontinuation and inform the trial if pregnancy occurs. For clarity, true abstinence is when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence, withdrawal, spermicides only or lactational amenorrhoea method for the duration of a trial, are not acceptable methods of contraception 7. Women of Child Bearing Potential (WOCBP) must have a negative urine pregnancy test before randomisation.
Exclusion criteria
Exclusion criteria: 1. Contraindications to treatment with bupropion: acute alcohol withdrawal; acute benzodiazepine withdrawal; history of mania; CNS tumour; current or past eating disorders; history of seizures; severe hepatic cirrhosis; concomitant use of monoamine oxidase inhibitors (MAOIs) 2. Contraindications to treatment with escitalopram: history of seizures; history of mania; QT-interval prolongation; known difficulty to control hypertension; active cardiac disease 3. Known hypersensitivity or allergies to escitalopram, bupropion or their excipients 4. Pharmacological treatment for depression in the past 6 weeks 5. Current medication for depression (e.g. with a mood stabiliser, antipsychotic or antidepressant), or any other dopaminergic, noradrenergic or serotonergic medication 6. Significant neurological impairment 7. Significant active suicidality 8. Current clinically significant substance use disorder 9. Clinically significant medical conditions under investigation or acute treatment 10. Pregnant, breastfeeding or planning pregnancy 11. Incomplete first online behavioural assessment & call
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reinforcement learning mechanism measured using a computer-based behavioural task at baseline, weeks 2 and 4 and optionally at weeks 24 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression measured using the Patient Health Questionnaire - 9 (PHQ-9) at Screening, Baseline, Week 2, 4, 6, 8, 24, 28 and 52 2. Health impairment measured using the Work and Social Adjustment Scale (WSAS) at Screening, Week 6, 8, 24, 52 3. Quality of Life measured using the ICEpop CAPability measure for Adults (ICECAP-A) at Screening, Week 6, 8, 24 and 52 4. Personality measured using the Big Five Inventory (BFI-10) at Screening 5. Anxiety Severity measured using the Generalised Anxiety Disorder Questionnaire (GAD-7) at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 6. Reward functioning measured using the Positive Valence Systems Scale (PVSS) at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 7. Activation/engagement measured using the Behavioral Activation for Depression Scale – Short Form (BADS-SF) BADS-SF at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 8. Hopelessness measured using the Brief Hopelessness scale at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 9. Rumination measured using the Ruminative Response Scale, brooding subscale at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 10. Negative emotion responses measured using the PERS negative activation subscale at Baseline, Week 2, 4, 6, 8, 24, 28 and 52 11. EEG parameters measured using optional EEG assessments at Baseline and Week 2 | — |
Countries
England, United Kingdom
Contacts
Public ContactMichaela Poppe
Outcome results
None listed