Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
- Conditions
- Interventions
- Registration Number
- NCT05401019
- Lead Sponsor
- Clinical Academic Center (2CA-Braga)
- Brief Summary
This is a phase 2, randomized, controlled clinical trial to study the efficacy of pramipexol or risperidone in the treatment of refractory ODC patients.
...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Age between 18 and 64 years;
- European Portuguese as mother tongue;
- Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria;
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;
- Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose with or without psychotherapy, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% to 35% relative to the score obtained before starting treatment with SSRIs (Rauch & Jenike, 1994).
- Patients who have a complete response to drug treatment with or without psychotherapy, i.e. patients with a reduction in Y-Bocs score by 25% to 35% regarding the score obtained before starting treatment with SSRIS (Rauch & Jenike, 1994);
- Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
- Patients with bipolar disorder;
- Patients with tick disorder;
- Patients with borderline personality disorder;
- Patients with social anxiety disorder;
- Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
- patients with a history of neurological disease or traumatic brain injury;
- Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
- patients who are passing or have passed in the last 6 months by a major depressive episode;
- Patients that undergo deep brain stimulation;
- Presence of sensory deficits impeding participation in clinical study;
- Pregnant or in breastfeeding period;
- Patients doing medication or receiving prohibited treatments;
- Patients with contraindication to perform MRI.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm Risperidone Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up. Experimental arm Pramipexole Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks
- Primary Outcome Measures
Name Time Method 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.
...
- Secondary Outcome Measures
Name Time Method Biochemical parameters Change from Baseline at visit 9 (16 weeks) Complete blood count, cortisol, adrenocorticotropic hormone, thyroxine and thyroid stimulating hormone values
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
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.
...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.
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.
Safety outcomes Change from Baseline at visit 9 (16 weeks) Number of adverse events
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).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.
...