Antidepressant treatment for depression in individuals with a confirmed genetic diagnosis of Huntington's Disease. Mental and Behavioural Disorders
Conditions
Interventions
Randomisation will take place online through a bespoke system built for the trial to maintain the blind.
Participants will be randomised to receive either 50mg of sertraline or Placebo daily for 6 mo
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult participants (age = 18), with a confirmed positive genetic test of HD 2. Presenting with a new episode of depression, defined by patient report of low mood and PBAs depressed mood item (i.e. not experiencing depressive symptoms for at least 4 months before the new episode) 3. Presenting with depressive symptomatology defined by patient report of low mood and PBAs depressed mood item score >1 for both severity and frequency
Exclusion criteria
Exclusion criteria: 1. Currently taking an antidepressant medication or have taken antidepressants in the last six months (for any indication) 2. A previous reaction and/or contraindication to sertraline, and/or Sertraline found to be ineffective 3. Any brain illness/injury, other than HD that, or medication in the opinion of the principal investigator, is likely to contribute to depressive symptoms 4. Any participant with severe depression (PBAs severity >3) or suicidal ideation (due to higher risk of deterioration and suicide in this group). 5. Not able to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes measured at 6 months post recruitment: 1. Recruitment 2. Retention 3. Data completeness 4. Medication adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression severity is measured using the Montgomery Asberg Depression Rating Scale (MADRS) at baseline, 8 weeks, and 6 months post randomisation 2. Depressive symptoms are measured using the Beck Depression Inventory-II (BDI-II) at baseline, 8 weeks, and 6 months post randomisation 3. Depressive symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 8 weeks, and 6 months post randomisation 4. Problem behaviours are measured using the Problem Behaviour Assessment at baseline, 8 weeks, and 6 months post randomisation 5. Suicidal ideation and behaviour are measured using the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline, 8 weeks, and 6 months post randomisation 6. Disability is measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) at baseline, 8 weeks, and 6 months post randomisation 7. Perceived social support is measured using the MOS Social Support Survey at baseline, 8 weeks, and 6 months post randomisation 8. Clinical progression of Huntington’s Disease is measured using the critical Unified Huntington’s Disease Rating Scale (cUHDRS) at baseline and 6 months 9. Motor function is measured using the motor assessment component of the cUHDRS at baseline and 6 months 10. Functional ability is measured using the functional assessment component of the cUHDRS at baseline and 6 months 11. Cognitive function, including association between visual association and memory/thought processing and cognitive inhibition, is measured using the cognitive assessment components of the cUHDRS at baseline and 6 months | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactPaula Foscarini-Craggs
Outcome results
None listed