ISRCTN84666271Active, not recruitingPhase 4
Randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 178
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Once informed consent has been given, participants will enter a run-in phase prior to randomisation.
- •Inclusion criteria for entry to run-in phase:
- •1. Willing and able to give informed consent to participate in the trial
- •2. Age 18 years or over
- •3. Diagnosis of DSM-V major depression
- •4. Quick Inventory of Depressive Symptomatology self-report version (QIDS-SR16) score >10 (moderate, severe or very severe depression)
- •5. Currently taking and tolerating antidepressant medication
- •6. 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
- •7. Indication for change in treatment
- •8. Willing to continue an antidepressant treatment
- •9. Negative urine pregnancy test result (in females of child-bearing potential only)
- •Inclusion criteria for entry to randomised phase:
- •1. Verbal consent to randomisation
- •2. QIDS-SR16 score >10
- •3. On a stable dose of an antidepressant for at least 4 weeks
Exclusion Criteria
- •Exclusion criteria for entry to run-in phase:
- •1. Diagnosis of current or previous psychosis, bipolar disorder or Parkinson’s Disease
- •2. Current antipsychotic medication
- •3. Clinically significant current or previous impulse control difficulties
- •4. Serious suicide or homicide risk
- •5. Current treatment with any medication known to interfere with pramipexole metabolism including cimetidine, memantine and methyldopa
- •6. Contraindications to pramipexole including history of or current treatment for eye disease, significant, symptomatic cardiovascular or renal disease or significant, symptomatic orthostatic hypotension
- •7. Previous course of pramipexole (>2 weeks duration)
- •8. 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
- •9. Female and pregnant, lactating or planning pregnancy
- •10. Female of child-bearing potential not willing to use effective contraception
- •Exclusion criteria for entry to randomised phase:
- •1. eGFR (from screening blood test) < 50 mL/min/1.73m2
- •2. Psychotherapy started in past 4 weeks or planned to start within next 12 weeks
Investigators
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