Trial · NCT05401019
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
NCT05401019, Phase 2, Withdrawn, Clinical Academic Center (2CA-Braga)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD). Trials, record NCT05401019. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05401019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
- NCT number
- NCT05401019
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Pramipexole, Risperidone
- First posted
- 2022-06-02
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2022-000249-34
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Y-BOCS total score | Change from Baseline Y-BOCS total score at visit 9 (16 weeks) | 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 |
| Secondary | Safety outcomes | Change from Baseline at visit 9 (16 weeks) | Number of adverse events |
| Secondary | Biochemical parameters | Change from Baseline at visit 9 (16 weeks) | Complete blood count, cortisol, adrenocorticotropic hormone, thyroxine and thyroid stimulating hormone values |
| Secondary | Neurobiological parameters | Change from Baseline at visit 9 (16 weeks) | 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 |
| Secondary | Scores of the 4 subscales of the WHOQOL-bref | Change from Baseline at visit 9 (16 weeks) | 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). |
| Secondary | OCI-R Total score | Change from Baseline at visit 9 (16 weeks) | 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. |
| Secondary | PSS-10 Total score | Change from Baseline at visit 9 (16 weeks) | 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. |
| Secondary | HAM-A Total score | Change from Baseline at visit 9 (16 weeks) | 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). |
| Secondary | HAM-D Total score | Change from Baseline at visit 9 (16 weeks) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05401019
GET https://conductscience.org/api/trials/v1/NCT05401019/registered