A Phase 3 interventional study of Pramipexole and Placebo in Bipolar Disorder (BD), sponsored by Daniel Lindqvist. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Daniel Lindqvist · Phase 3, Interventional, and Treatment
Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes.
There will be a 15 weeks open label follow up. If shown to be effective and safe, this intervention could become a key treatment option for bipolar depression, reducing suffering and potentially lowering suicide risk.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 126 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Daniel Lindqvist is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 weeks of treatment with the dopamine agonist pramipexole adjunctive to a mood stabilizer. Target dose 2.1 mg base/day.
Drug: Pramipexole
6 weeks of treatment with placebo adjunctive to a mood stabilizer.
Drug: Placebo
6 weeks of treatment with the dopamine agonist pramipexole adjunctive to a mood stabilizer. Target dose 2.1 mg base/day.
6 weeks of treatment with a placebo for the dopamine agonist pramipexole adjunctive to a mood stabilizer.
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.
Time frame: Between baseline visit and week 6
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.
Time frame: Between baseline visit and week 21
Change in sedentary behaviour (SED) between baseline, week 6 and week 21
Parameter is part of determining physical activity measured by wearable activity meters
Time frame: Between baseline and week 21
Change in light physical activity (LPA) between baseline, week 6 and week 21
Parameter is part of determining physical activity measured by wearable activity meters
Time frame: Between baseline and week 21
Change in moderate- to vigorous physical activity (MVPA) between baseline, week 6 and week 21
Parameter is part of determining physical activity measured by wearable activity meters
Time frame: Between baseline and week 21
Change in Dimensional Anhedonia Rating Scale (DARS) from baseline to week 6 and 21
Scale consists of 17 items divided into four subdomains (Hobbies, Food/Drinks, Social Activities and Sensory Experiences). Each item is scored on a 5-point Likert scale ranging from 1 to 5. Higher score indicates greater ability to experience pleasure representing less anhedonia. Score range: 17 to 85.
Time frame: Between baseline visit and week 21
Change in Apathy Evaluation Scale (AES) from baseline to week 6 and 21
Scale consists of 18 items designed to measure aspects like goal-directed behavior, interest, and emotional responsiveness. Each question is scored on a Likert scale from 1 to 4, resulting in a total score ranging from 18 to 72, where higher scores indicate greater apathy.
Time frame: Between baseline visit and week 21
Change in Clinical Global Impression - Severity (CGI-S) between baseline, week 6 and 21
7-point scale that measures overall severity of a patient's mental illness with higher scores indicating more severe illness. Score range: 1 to 7.
Time frame: Between baseline and week 21
Change in EuroQol - Five dimensions - Five levels (EQ-5D-5L) between baseline, week 6 and 21
Patient evaluates their health across five core dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. For each dimension, the patient selects one of five severity levels that best describes their state: 1: No problems, 2: Slight problems, 3: Moderate problems, 4: Severe problems, 5: Extreme problems. These responses are combined into a 5-digit number (e.g., "11121" indicates no problems across the board except for slight pain/discomfort). This score is then converted into a total index value using country-specific population value sets. In addition, the patient rates their overall health on a vertical visual analogue scale that looks like a thermometer. 0: The worst health you can imagine vs 100: The best health you can imagine.
Time frame: Between baseline and week 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Young Mania Rating Scale (YMRS)
The YMRS evaluates symptoms over the preceding 48 hours using an 11-item questionnaire: Elevated mood, increased motor activity, sleep patterns, sexual interest, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Scoring Weights: Seven items are rated on a severity scale of 0 to 4. Four core items are double-weighted (scored 0 to 8) to reflect their clinical significance: irritability, speech, thought content, and disruptive/aggressive behavior. Total scores range from 0 to 60, with higher numbers indicating more severe mania. ≤ 12: Typically indicates remission of manic symptoms.≥ 20: Generally corresponds to moderate-to-severe mania.
Time frame: Between baseline visit and week 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Modified Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (M-QUIP-RS)
The scale is designed to evaluate seven primary impulse and compulsive behaviors: Compulsive gambling, Excessive buying/shopping, Binge-eating, Hypersexuality, Punding (intense fascination with repetitive handling or sorting of ordinary objects), Hobbyism (performing a hobby or task to an excessive degree), Dopamine Dysregulation Syndrome (DDS). The questionnaire features 4 questions for each of the 7 subdomains. Scoring: Patients or caregivers rate the severity of behaviors over the past month using a 5-point Likert scale (0 to 4). Total Score: Individual subscales range from 0 to 16, with a total overall score scaling up to 112.
Time frame: Between baseline visit and week 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Modified Problem Gambling Severity Index (M-PGSI)
9-item questionnaire using a 4-point scale for each question: 0 (never) to 3 (almost always). The scores are totaled to produce a final result between 0 and 27: Score of 0: Non-problem gambling. You may gamble, but you do not report experiencing adverse consequences. Score of 1 to 2: Low-risk. You are unlikely to experience adverse consequences but may be at risk if heavily involved. Score of 3 to 7: Moderate-risk. You may have experienced some negative consequences and show signs of risky habits. Score of 8 or higher: Problem gambling. You are likely to experience severe adverse consequences and may have lost control of your behavior.
Time frame: Between baseline visit and week 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Alcohol Use Disorders Identification Test (AUDIT)
10-question screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Core Domains: Frequency of drinking, typical intake, binge drinking, loss of control, and guilt. Scale of 0 to 4 fro each item depending on frequency: 0 = Never, 1 = Less often than once a month, 2 = Every month, 3 = Every week, 4 = Daily or almost every day. Scoring: Scores range from 0 to 40. A score of 8+ typically indicates hazardous or harmful consumption.
Time frame: Between baseline visit and week 21
Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Drug Use Disorders Identification Test (DUDIT)
11-item self-report questionnaire designed to screen for drug-related problems, substance abuse, and dependence. Respondents answer the 11 questions using a scale of 0 to 4 depending on frequency: 0 = Never, 1 = Less often than once a month, 2 = Every month, 3 = Every week, 4 = Daily or almost every day. The 11 Items: The questionnaire includes 11 items covering frequency of drug use, consumption habits, inability to control usage, neglect of responsibilities, and physical/psychological consequences. 0 to 44 points in total, uses gender-specific cut-offs to determine risk levels, where scores of 6+ (women) or 8+ (men) often indicate potential dependence.
Time frame: Between baseline visit and week 21
Clinical improvement per structured clinical assessments
e.g. Association for Methodology and Documentation in Psychiatry
Time frame: 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
Time frame: Between baseline visit and week 21
Changes in Blood-oxygen-level dependent imaging (BOLD) activity
In the nucleus accumbens during fMRI with the Monetary Incentive Delay (MID) task between baseline and week 6
Time frame: Between baseline and week 6
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.
Time frame: Between baseline and week 21
Change in total sleep time (TST)
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Time frame: Between baseline and week 21
Change in wake after sleep onset (WASO)
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Time frame: Between baseline and week 21
Change in number of awakenings (NA)
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Time frame: Between baseline and week 21
Concentration of pramipexole in the blood serum
In the open-label phase (Week 9, 12 and 18)
Time frame: Week 9 to 18
Patient's personal experience with pramipexole treatment
Qualitative interview with a phenomenological approach. We aim to describe the experience of treatment with pramipexole (focusing on tolerability and improvement) in patients with bipolar depression.
Time frame: During open-label phase (week 6 to 21)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.
Of 43 phase 3 interventional studies under Bipolar Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's planned 38 months is close to that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Pramipexole
Daniel Lindqvist