Trial · NCT06611592
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference between baseline and after treatment in Y-BOCS total score | Baseline and Week 16 | The measurement of the difference in the total score of the Y-BOCS scale between baseline (before intervention with the investigational drug) and after intervention with the investigational drug, between the different groups treated with different doses of pramipexole. The Y-BOCS scale measures obsessions separately from compulsions and specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards or against the type of content the obsessions or compulsions might present. The final scores range from 0 to 40, with higher scores indicating higher symptom severity. The scores indicate subclinic (0 - 7 points), mild (8 - 15 points), moderate (16 - 23 points), severe (24 - 31 points), and extreme severity (32 - 40 points). |
| Secondary | Number of adverse events observed | From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study) | Number of adverse events observed (nonserious, serious not related to the investigational medicinal product, and serious related to the investigational medicinal product) |
| Other | OCI-R Total score | Baseline, Day 1, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22 | Obsessive-Compulsive Inventory-Revised (OCI-R) is a self-report instrument that assesses the symptoms of OCD during the last month through 18 statements that are related to everyday situations. The total score ranges from 0 to 72 points. Higher scores on this scale indicate higher severity of OCD symptoms. |
| Other | Scores of the 4 subscales of the WHOQOL-bref | Baseline (before intervention), Week 16 (after intervention ), and Week 22 (end of study) | The Quality of Life Scale (WHOQOL-bref) is an instrument that assesses four conceptual domains of quality of life: material and physical well-being, relationships with other people, psychological well-being and environment. This self-report instrument, consisting of a brief sociodemographic questionnaire and 26 statements, quantifies global cognitive judgments of life satisfaction. |
| Other | HAM-D Total score | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22 | Hamilton Depression Rating Scale (HAM-D) instrument to measure the psychic and somatic components of depression. From 0 - 7 the participant is considered asymptomatic, while a score equal to or greater than 20 indicates the presence of depressive symptoms. The higher the value, the greater the severity of the symptoms, ranging from moderate to severe. |
| Other | HAM-A Total score | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22 | Hamilton Anxiety Rating Scale (HAM-A) instrument to measure the psychic and somatic components of anxiety. The final scores indicate: mild anxiety (0 - 17 points), moderate anxiety (18 - 24 points) and potentially worrying levels of anxiety (25 - 30 points). |
| Other | PSS-10 Total score | Baseline, Day 1, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22 | Perceived Stress Scale (PSS-10) is a self-report questionnaire to assess perceived stress during the last month. The total score can vary between 0 and 40 points. A higher total score indicates higher levels of perceived stress. |
| Other | SIQ total score | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 16, Week 18 and Week 22 | The Suicidal Ideation Questionnaire (SIQ) assesses thoughts and cognitions about suicide and death over the past month. Higher scores in the SIQ scale represent greater severity of suicidal ideation. The total score ranges from 0 to 180 points. |
| Other | Neurobiological parameters - Cortical thickness | Baseline (before intervention) and Week 16 (after intervention with the investigational drug). | Anatomical sequence (Magnetization Prepared - RApid Gradient Echo) to assess cortical thickness |
| Other | Neurobiological parameters - Functional connectivity | Baseline (before intervention) and Week 16 (after intervention with the investigational drug). | Functional sequences (Echo-planar imaging) at rest to assess functional connectivity of neural networks and static and dynamic connectivity |
| Other | Neurobiological parameters - Brain activity | Baseline (before intervention) and Week 16 (after intervention with the investigational drug). | Functional sequences (Echo-planar imaging) during an emotional processing task to assess brain activation during emotional processing |
| Other | Neurobiological parameters - Diffusion | Baseline (before intervention) and Week 16 (after intervention with the investigational drug). | Diffusion sequences (Diffusion Weighted Imaging) to measure mean diffusivity (MD), fractional anisotropy (FA), axial diffusivity (AD) and radial diffusivity (RD), in order to assess white matter integrity. |
| Other | Biochemical parameters - Complete blood count | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the complete blood count. |
| Other | Biochemical parameters - Cortisol | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the cortisol. |
| Other | Biochemical parameters - ACTH | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the adrenocorticotropic hormone (ACTH). |
| Other | Biochemical parameters - T4 | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the thyroxine (T4). |
| Other | Biochemical parameters - TSH | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the thyroid stimulating hormone (TSH). |
| Other | Biochemical parameters - creatinine | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the creatinine. |
| Other | Biochemical parameters - glucose | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the glucose. |
| Other | Biochemical parameters - glycated hemoglobin | Baseline (before intervention ), Week 16 (after intervention) and Week 22 (end of the study) | Blood samples will be collected to measure the glycated hemoglobin. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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