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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000249-34 | EudraCT Number |
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This clinical trial was not approved by the regulatory entities. It was reviewed and a new trial was re-submitted.
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| Name | Class |
|---|---|
| University of Minho | OTHER |
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This is a phase 2, randomized, controlled clinical trial to study the efficacy of pramipexol or risperidone in the treatment of refractory ODC patients.
This study is a two-parallel-group clinical trial with duration of 28 weeks (recruitment phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 8 weeks. The primary endpoint of this study is the score in the Y-BOCS scale measured between baseline and EOT ( at week 16).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks |
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| Control arm | Active Comparator | Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug | Oral medication, once a day during 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Y-BOCS total score | Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score. 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. This instrument consists of 10 self-report items (5 items for obsessions, 5 items for compulsions) that estimate the degree of severity of symptoms (subclinical, mild, moderate, severe or extreme) on a Likert scale ranging from 0 (no symptoms) and 4 (extreme). The final score is calculated as the total sum of all items: subclinical (0 - 7 points), mild (8 - 15 points), moderate (16 - 23 points), severe (24-31) and extreme (32 - 40 points). In the final score, 16 is the cut-off point for symptom severity to be indicative of OCD | Change from Baseline Y-BOCS total score at visit 9 (16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes | Number of adverse events | Change from Baseline at visit 9 (16 weeks) |
| Biochemical parameters | Complete blood count, cortisol, adrenocorticotropic hormone, thyroxine and thyroid stimulating hormone values |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Risperidone |
| Drug |
Oral medication, once a day during 16 weeks |
|
| Change from Baseline at visit 9 (16 weeks) |
| Neurobiological parameters | Cortical thickness; functional connectivity of neural networks and static and dynamic connectivity; brain activation during symptom induction; mean diffusivity, fractional anisotropy, axial diffusivity and radial diffusivity | Change from Baseline at visit 9 (16 weeks) |
| Scores of the 4 subscales of the WHOQOL-bref | 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. The final score for each domain is calculated by adding up all the statements corresponding to that domain (D1: Physical - 7 items; D2: Psychological - 6 items; D3: Social Relations - 3 items; D4: Environment - 8 items). | Change from Baseline at visit 9 (16 weeks) |
| OCI-R Total score | Obsessive-Compulsive Inventory-Revised (OCI-R) is an self-report instrument that assesses the symptoms of OCD during the last month through 18 statements that are related to everyday situations. The final score is calculated as the total sum of all items, ranging from 0 to 72, with a score greater than 20 indicative of severe symptoms of OCD. | Change from Baseline at visit 9 (16 weeks) |
| PSS-10 Total score | Perceived Stress Scale (PSS-10) is a self-report questionnaire to assess perceived stress during the last month. The questionnaire's score is obtained by the sum of the answers in each item, which can vary between 0 and 40 points. | Change from Baseline at visit 9 (16 weeks) |
| HAM-A Total score | Hamilton Anxiety Rating Scale (HAM-A) instrument to measure the psychic and somatic components of anxiety. The final score is calculated as the sum total of all items: mild anxiety (0 - 17 points), moderate anxiety (18 - 24 points) and potentially worrying levels of anxiety (25 - 30 points). | Change from Baseline at visit 9 (16 weeks) |
| HAM-D Total score | Hamilton Depression Rating Scale (HAM-D) instrument to measure the psychic and somatic components of depression. The final score is calculated as the sum total of all items, 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. | Change from Baseline at visit 9 (16 weeks) |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |