Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
NCT07664852, Phase 3, Recruiting, Daniel Lindqvist
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression | ClinicalTrials.gov |
| NCT number | NCT07664852 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 126 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Daniel Lindqvist | ClinicalTrials.gov |
| Conditions | Bipolar Disorder (BD) | ClinicalTrials.gov |
| Interventions | Pramipexole, Placebo | ClinicalTrials.gov |
| First posted | 2026-06-24 | ClinicalTrials.gov |
| Last updated | 2026-10-22 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline | Between baseline visit and week 6 | 14 items rated from points with 1 to 4. Higher scores equal more severe anhedonia. Score range: 14-56. | ClinicalTrials.gov |
| Secondary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 and week 21 | Between baseline visit 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. | ClinicalTrials.gov |
| Secondary | Change in sedentary behaviour (SED) between baseline, week 6 and week 21 | Between baseline and week 21 | Parameter is part of determining physical activity measured by wearable activity meters | ClinicalTrials.gov |
| Secondary | Change in light physical activity (LPA) between baseline, week 6 and week 21 | Between baseline and week 21 | Parameter is part of determining physical activity measured by wearable activity meters | ClinicalTrials.gov |
| Secondary | Change in moderate- to vigorous physical activity (MVPA) between baseline, week 6 and week 21 | Between baseline and week 21 | Parameter is part of determining physical activity measured by wearable activity meters | ClinicalTrials.gov |
| Secondary | Change in Dimensional Anhedonia Rating Scale (DARS) from baseline to week 6 and 21 | Between baseline visit and week 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. | ClinicalTrials.gov |
| Secondary | Change in Apathy Evaluation Scale (AES) from baseline to week 6 and 21 | Between baseline visit and week 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. | ClinicalTrials.gov |
| Secondary | Change in Clinical Global Impression - Severity (CGI-S) between baseline, week 6 and 21 | Between baseline and week 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. | ClinicalTrials.gov |
| Secondary | Change in EuroQol - Five dimensions - Five levels (EQ-5D-5L) between baseline, week 6 and 21 | Between baseline and week 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. | ClinicalTrials.gov |
| Secondary | Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Young Mania Rating Scale (YMRS) | Between baseline visit and week 21 | 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. | ClinicalTrials.gov |
| Secondary | 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) | Between baseline visit and week 21 | 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. | ClinicalTrials.gov |
| Secondary | Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Modified Problem Gambling Severity Index (M-PGSI) | Between baseline visit and week 21 | 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. | ClinicalTrials.gov |
| Secondary | Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Alcohol Use Disorders Identification Test (AUDIT) | Between baseline visit and week 21 | 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. | ClinicalTrials.gov |
| Secondary | Systematic registration of adverse events, especially (hypo)mania and impulse control related symptoms: Drug Use Disorders Identification Test (DUDIT) | Between baseline visit and week 21 | 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. | ClinicalTrials.gov |
| Other | Clinical improvement per structured clinical assessments | Between baseline visit and week 21 | e.g. Association for Methodology and Documentation in Psychiatry | ClinicalTrials.gov |
| Other | Digital neuropsychological test battery | Between baseline visit and week 21 | 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 | ClinicalTrials.gov |
| Other | Changes in Blood-oxygen-level dependent imaging (BOLD) activity | Between baseline and week 6 | In the nucleus accumbens during fMRI with the Monetary Incentive Delay (MID) task between baseline and week 6 | ClinicalTrials.gov |
| Other | Relevant blood, CSF, and fMRI biomarkers | Between baseline and week 21 | 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. | ClinicalTrials.gov |
| Other | Change in total sleep time (TST) | Between baseline and week 21 | Parameter is part of analysing changes in sleep pattern measured by wearable activity meters | ClinicalTrials.gov |
| Other | Change in wake after sleep onset (WASO) | Between baseline and week 21 | Parameter is part of analysing changes in sleep pattern measured by wearable activity meters | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Other outcome | ConductCognition |
| Monetary Incentive Delay | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)