ISRCTN84666271
Active, not recruiting
Phase 4
Randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford
- Enrollment
- 178
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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