Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression

14 items rated from points with 1 to 4. Higher scores equal more severe anhedonia. Score range: 14-56.

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.

Parameter is part of determining physical activity measured by wearable activity meters

Parameter is part of determining physical activity measured by wearable activity meters

Parameter is part of determining physical activity measured by wearable activity meters

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.

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.

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.

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.

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.

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.

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.

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.

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.

e.g. Association for Methodology and Documentation in Psychiatry

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

In the nucleus accumbens during fMRI with the Monetary Incentive Delay (MID) task between baseline and week 6

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.

Parameter is part of analysing changes in sleep pattern measured by wearable activity meters

Parameter is part of analysing changes in sleep pattern measured by wearable activity meters

Parameter is part of analysing changes in sleep pattern measured by wearable activity meters

In the open-label phase (Week 9, 12 and 18)

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.