2026-526383-20-00招募中3 期
B-HAPPI: Bipolar disorder and high-dose adjunctive pramipexole for anhedonic depression – a phase III, double-blind, randomized controlled trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change in SHAPS self-rating scale between baseline and week 6
研究概览
简要总结
To evaluate the efficacy of adjunctive pramipexole, compared to placebo, in reducing anhedonia over 6 weeks in patients with bipolar disorder in a current depressive episode.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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-
- •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.
- •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.
排除标准
- •Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification.
- •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).
- •Meets criteria for a mixed episode according to ICD-
- •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.
研究组 & 干预措施
Placebo tablets for oral administration matching the commercially available 0.26 mg, 0.52 mg, 1.05 mg, and 2.10 mg of base Pramipexole AL oral tablets
Placebo
干预措施: Placebo tablets for oral administration matching the commercially available 0.26 mg, 0.52 mg, 1.05 mg, and 2.10 mg of base Pramipexole AL oral tablets (Drug)
结局指标
主要结局
Change in SHAPS self-rating scale between baseline and week 6
Change in SHAPS self-rating scale between baseline and week 6
次要结局
- Change in MADRS expert rating scale between baseline and week 6
- Accelerometery data analysing 24-hour movement behaviour, including physical activity. Change in Sedentary Behaviour (SED), Low-Intensity Physical Activity (LPA) and Moderate- to Vigorous Physical Activity (MVPA), between baseline and every post-baseline visit.
- Change in DARS and AES scores between baseline and week 6
- Change in CGI-S and EQ-5D-5L between baseline and week 6
- Systematic registration of AEs and SAEs, with focus on (hypo)manic symptoms (YMRS) and impulse control related symptoms using relevant items from the M-QUIP-RS and M-PGSI. We will also assess alcohol and substance abuse using the Alcohol/Drug Use Disorders Identification Tests (AUDIT/DUDIT) at baseline, week 6 and week 15.
- Extension phase, open-label follow-up study for up to 15 weeks after RCT phase, including the same rating scales, clinical and safety assessments as in the RCT phase.
- Clinical improvement per structured clinical assessments (e.g. Association for Methodology and Documentation in Psychiatry)
- Digital neuropsychological test battery comprising the 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
- BOLD activity in the reward system during fMRI with the MID task
- Relevant blood, CSF, and fMRI biomarkers. Genetic variants linked to dopamine, inflammation, cellular health (incl. neurodegeneration and biomarkers of brain injury), cellular stress and metabolism, growth factors and monoamine turnover (and its receptors), the blood-brain barrier and its drug transporters, and the concentration of the investigational drug. Biomarker assays will be prioritised based on scientific relevance and available funding
- Accelerometery data analysing 24-hour movement behaviour, including sleep. Change in sleep patterns total sleep time (TST), wake after sleep onset (WASO), and number of awakenings (NA) between baseline and every post-baseline visit.
- Assessment of pramipexole levels in serum samples
- Qualitative interviews with a phenomenological approach. We aim to describe the experience of treatment with pramipexole (focusing on tolerability and improvement) in patients with bipolar depression.
- All outcome measures will be analysed stratified by bipolar subtype in exploratory analyses
- Change in CD-RISC-25
- Relevant blood, CSF, and fMRI biomarkers and genetic variants linked to dopamine, inflammation, cellular health (incl. neurodegeneration and biomarkers of brain injury), cellular stress and metabolism, growth factors and monoamine turnover (and its receptors), the blood-brain barrier and its drug transporters, and the concentration of the investigational drug. Change in DNA methylation patterns. Biomarker assays will be prioritised based on scientific relevance and available funding.
研究者
Daniel Lindqvist
Scientific
Region Skane
研究点 (1)
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