Pramipexole for Bipolar Depression (Pax-BD)

Phase 1

• Conditions: Bipolar disorder (BD); MedDRA version: 20.0Level: LLTClassification code 10012386Term: Depression mentalSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-002869-18-GB
• Lead Sponsor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Stage 1/ pre-randomisation:
1. Currently under the care of secondary care mental health services at screening with a plan for the patient to remain in secondary care throughout the period of the trial.
2. A decision made by the patient’s clinical team that a change in medication is indicated.
3. A current diagnosis of Bipolar Disorder (type I or II), defined as in DSM-5, which is supported by the use of the Mini-International Neuropsychiatric Interview (MINI) (52).
4. Currently depressed, i.e. meeting DSM-5 criteria for a Major Depressive Episode assessed via MINI and with a current QIDS-SR >10.
5. Current episode of depression failed to have responded to adequate trials, or lack of tolerability or patient refusal, of two different NICE recommended medications (quetiapine, olanzapine + fluoxetine, lamotrigine) or lurasidone. Adequacy of treatment trial defined using a custom designed ‘Bipolar Depression Treatment Questionnaire’ (BDTQ).
6. Aged 18 or over at the point of consent.
7. Willing and able to provide written informed consent prior to any trial procedures taking place.
8. In the opinion of the investigator, is able to follow the trial prescription instructions and is able to manage 8 weeks supply of trial medication without risk of overdose.
9. The patient, if female and of child-bearing potential, must have a negative pregnancy test [urine beta-human chorionic gonadotropin (ß-hCG].
10.Women of child-bearing potential are required to use a highly effective contraceptive method during the pre-randomisation and post-randomisation phase of the trial. Highly effective methods of contraception include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)
- bilateral tubal occlusion
- sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject)

Stage 2/ at randomisation:
1. Currently depressed, i.e. meeting DSM-5 (53) criteria for a Major Depressive Episode and with a current QIDS-SR >10.
2. A minimum of two telephone phone calls with a trial RA and two on-line weekly symptom ratings have been completed during the pre-randomisation phase
3. On mood stabilising medication (lithium, valproate, carbamazepine, lamotrigine)
4. All regular psychotropic medication, including mood stabilisers, at a stable dose for a minimum of four weeks
5. The patient, if female and of childbearing potential, must have a negative pregnancy test [urine beta-human chorionic gonadotropin (ß-hCG).
6. Women of child-bearing potential are required to use a highly effective contraceptive method during the post-randomisation phase of the trial. Highly effective methods of contraception include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- progestogen

Exclusion Criteria

Stage 1/ pre-randomisation:
1. DSM-5 defined severe substance use disorder.
2. Current psychotic symptoms as assessed using the MINI.
3. History of retinal disease.
4. Current cardiovascular symptoms or significant concerns around cardiovascular disease.
5. History of renal disease.
6. Any known sensitivity to trial drug including its excipients.
7. Current pregnancy or planned pregnancy during the trial period, or breast feeding.
8. Starting specific psychotherapy from four weeks before randomisation through to Week 12 post-randomisation.
9. Currently taking part in another clinical trial that would interfere with the outcomes of PAX-BD (site team to check with the CI and Trial Management Group if in doubt).
10. Confirmed diagnosis with potential confounding factors such as Parkinson’s disease, restless leg syndrome.
11. Clinical concern of previous impulse control behaviours including harmful alcohol or drug use, binge eating, gambling or sexual behaviours, or regarding significant suicidal risks.

Stage 2/ at randomisation:
1. Psychotic symptoms over the preceding 4 weeks.
2. Any known sensitivity to trial drug including its excipients
3. Any deterioration in physical or mental health since pre-randomisation that means there is a clinical concern to proceed with the study.
4. On an antipsychotic at the point of randomisation.
5. Current or planned pregnancy during the trial period, or breast feeding.
6. Starting specific psychotherapy from four weeks before randomisation through to Week 12 post-randomisation.
7. Currently taking part in another clinical trial that would interfere with the outcomes of PAX-BD (site team to check with the CI and Trial Management Group if in doubt).
8. Confirmed diagnosis with potential confounding factors such as Parkinson’s disease, restless leg syndrome.
9. Clinical concern of previous impulse control behaviours including harmful alcohol or drug use, binge eating, gambling or sexual behaviours or regarding significant suicidal risks.
10. Any study team’s concern regarding the patient’s ability to remain engaged in the study collecting self-ratings of their symptoms.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified