Pramipexole vs Placebo Treatment in Bipolar Disorder With... | NCT07664852

NCT07664852

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2026-526383-20-00	EU Trial (CTIS) Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Pramipexole-treated	Experimental	6 weeks of treatment with the dopamine agonist pramipexole adjunctive to a mood stabilizer. Target dose 2.1 mg base/day.	Drug: Pramipexole
Placebo-treated	Placebo Comparator	6 weeks of treatment with placebo adjunctive to a mood stabilizer.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole	Drug	6 weeks of treatment with the dopamine agonist pramipexole adjunctive to a mood stabilizer. Target dose 2.1 mg base/day.	Pramipexole-treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline	14 items rated from points with 1 to 4. Higher scores equal more severe anhedonia. Score range: 14-56.	Between baseline visit and week 6

Secondary Outcomes

Measure	Description	Time Frame
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 and week 21	10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression. Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.	Between baseline visit and week 21

Other Outcomes

Measure	Description	Time Frame
Clinical improvement per structured clinical assessments	e.g. Association for Methodology and Documentation in Psychiatry	Between baseline visit and week 21
Digital neuropsychological test battery	Trail Making Test, Rey Auditory Verbal Learning Test, Click Reaction Time, Victoria Stroop Test, Digital Corsi Block-Tapping Test, Symbol Digit Processing Test, and the Verbal Fluency Test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant has given their written consent to participate in the trial.
For WOCBP, adequate contraception should be used (see section 9.6) and a negative pregnancy test is (u-hCG) required. WOCBP: For the purpose of this protocol, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Age ≥18 years ≤80 years.
Diagnosis of bipolar disorder type I or II as verified by ICD-11.
Ongoing depressive state according to ICD-11 (at least 2 weeks, maximum 18 months).
Significant anhedonia, defined as 3 or 4 points on ≥3 items on the SHAPS self-rating scale
Minimum score on the MADRS expert rating scale ≥ 20
Ongoing treatment with at least one mood stabilising agent (with sufficient antimanic protection as determined by clinical judgment). If treatment with lithium is ongoing, serum levels must be within the reference range of 0.4-0.9. The latest concentration measurement should be within one month before treatment initiation. If treatment is ongoing with a mood stabilising anticonvulsant or an antipsychotic, any dose adjustments made within 4 weeks prior to study start must be reported. Mood-stabilising anticonvulsants and antipsychotics must not be newly initiated within 4 weeks prior to study start. If treatment with antidepressants is ongoing the dose must have been stable for at least 4 weeks.

Exclusion Criteria:

Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification.
Meets criteria for a mixed episode according to ICD-11.
High suicide risk according to the overall clinical assessment of the research physician.
Ongoing substance abuse (within 6 months).
Ongoing psychotic symptoms.
Prior diagnosis of schizophrenia or schizoaffective disorder.
Clinical presentation is primarily attributable to a personality disorder.
Subject to compulsory psychiatric care (LPT).
History of, or strong clinical suspicion of, impulse control disorder (including current binge-eating disorder). A diagnosis of ADHD is not, in itself, an exclusion criterion; however, participants will be excluded if the clinical presentation is primarily characterised by impulse control-related symptoms.
Diagnosis of intellectual disability, dementia, cognitive impairment, or other conditions (including those related to the depressive disorder itself) that, in the judgment of the study physician, may substantially impair the participant's ability to understand the study and provide informed consent.
Diagnosis of renal failure (eGFR <50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure >Class II New York Heart Association (NYHA)).
Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial. Psychoeducational treatment, which is standard care at bipolar units, is not an exclusion criterion.
Ongoing treatment with ECT, ketamine or rTMS.
Other medical conditions, other ongoing interventions or other concomitant drug treatment (see section 7.3) that, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example: Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year.
Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
Participation in other treatment studies.
Other reason, as assessed by the investigator, that prevents the research participant's participation, such as the risk that the research participant is unable to complete the trial (non-compliance).

ID	Term
D001714	Bipolar Disorder
D059445	Anhedonia

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring