Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611592
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder OCD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder OCD Pilot Randomized and Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCD-RT
Brief Summary:
The most common and effective treatment for OCD is pharmacological therapy that includes selective serotonin reuptake inhibitors SSRIs antidepressants and in the case of patients resistant to this approach a combination with antipsychotics Risperidone and aripiprazole are atypical antipsychotics that act on dopamine D2 and serotonin receptors Studies have shown that these drugs are effective in boosting SSRIs for the treatment of OCD in resistant patients
Currently a high percentage of people diagnosed with OCD do not respond to the existing treatments Pramipexole is a dopaminergic receptor agonist that specifically binds to dopamine D2 and D3 receptors having demonstrated benefit in resistant depression
The aim of this clinical trial is to explore how pramipexole can act in the treatment of OCD in resistant patients evaluating its safety and efficacy
Currently a high percentage of people diagnosed with OCD do not respond to the existing treatments Pramipexole is a dopaminergic receptor agonist that specifically binds to dopamine D2 and D3 receptors having demonstrated benefit in resistant depression
The aim of this clinical trial is to explore how pramipexole can act in the treatment of OCD in resistant patients evaluating its safety and efficacy
Detailed Description:
Phase 2 clinical trial randomized with three-parallel-groups lasting 26 weeks screening phase 4 weeks treatment phase 16 weeks follow-up phase 6 weeks whose primary objective is to evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs in three different doses in treatment of resistant OCD
The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline V1 before intervention with the investigational drug and week 16 V9 after intervention with the investigational drug between the different groups treated with different doses of pramipexole
The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline V1 before intervention with the investigational drug and week 16 V9 after intervention with the investigational drug between the different groups treated with different doses of pramipexole
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None