PAX-D
Overview
We are looking for adults who are currently experiencing treatment-resistant depression. This means you will have tried two or more antidepressants but still feel depressed.
We are testing whether adding a medication, pramipexole, to your regular antidepressants reduces symptoms of depression more than a placebo.
To participate you must be aged 18 or over, have depression, have tried two or more antidepressants, and have no history of psychosis, bipolar depression, or impulse control disorders.
Are you interested in taking part in this study?
Find out more by filling in this form
Planned end date
30 Nov 2024 20:40Conditions
DepressionInclusion Criteria
Inclusion criteria for entry to run-in phase:
- Willing and able to give informed consent to participate in the trial
- Age 18 years or over
- Clinical diagnosis of DSM-V major depression** based on the affective disorder sections of the Mini International Neuropsychiatric Interview (MINI). N.b. comorbid anxiety disorder is not an exclusion criterion
- Quick Inventory of Depressive Symptomatology self-report version (QIDS-SR16) score > 10 (moderate, severe or very severe depression)
- Currently taking antidepressant medication
- A lack of response to at least 2 antidepressants at therapeutic doses (based on Maudsley Prescribing Guidelines and/or British National Formulary) in the current episode
- An indication for change in treatment
- Willing to continue an antidepressant treatment
- Women of child-bearing potential (WOCBP) only – a negative urine pregnancy test result
Additional inclusion criteria for entry to the randomised phase:
- Verbal consent to randomisation
- QIDS-SR16 score > 10
- On a stable dose of an antidepressant for at least 4 weeks
- Women of child-bearing potential only - a negative pregnancy test result
Exclusion Criteria
Exclusion criteria for entry to run-in phase:
- Clinical diagnosis of current or previous psychosis, bipolar disorder or Parkinson’s Disease
- Currently taking an antipsychotic medication.
- Clinically significant current or previous impulse control difficulties
- Serious suicide or homicide risk
- Current treatment with any medication known to interfere with pramipexole metabolism including cimetidine, memantine and methyldopa.
- Contraindications to pramipexole including history of or current treatment for eye disease (excluding near or long-sightedness), significant, symptomatic cardiovascular or renal disease or significant, symptomatic orthostatic hypotension
- Previous course of pramipexole (> 2 weeks)
- Untreated or unstable medical condition which, in the judgement of the investigator, could interfere with the safety of receiving pramipexole or ability to complete the trial
- Female and pregnant, lactating or planning pregnancy
- Woman of child-bearing potential not willing to use effective contraception
Exclusion criteria for entry to randomised phase:
- Insufficient completion of questionnaires scheduled during the run-in phase (defined as at least 75% completion)
- Has not responded to Research Assistant contact during the run-in phase
- eGFR (from screening blood test) < 50 mL/min/1.73m2
- Psychotherapy started in past 4 weeks or planned to start within next 12 weeks
