Is pramipexole effective as an add-on treatment for people with treatment-resistant depression?

Phase 4

• Conditions: Treatment resistant depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN84666271
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Last Update Posted: 10 June 2024
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified