Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD) (OCD-RT)

Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD): Randomized Controlled Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Drug: Pramipexole; Drug: Risperidone

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 64 years;
2. European Portuguese as mother tongue;
3. Patients diagnosed with OCD, regardless of subtype, according to DSM-5 and/or ICD-10 criteria;
4. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥ 16;
5. 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).

Exclusion Criteria:

1. 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);
2. Patients with current or anterior history of psychotic illness (schizophrenia, delusions, among others);
3. Patients with bipolar disorder;
4. Patients with tick disorder;
5. Patients with borderline personality disorder;
6. Patients with social anxiety disorder;
7. Patients with current or anterior history of dietary behavior disorders (at least in the last 6 months);
8. patients with a history of neurological disease or traumatic brain injury;
9. Patients with history of alcohol abuse or illicit substances (at least in the last 6 months);
10. patients who are passing or have passed in the last 6 months by a major depressive episode;
11. Patients that undergo deep brain stimulation;
12. Presence of sensory deficits impeding participation in clinical study;
13. Pregnant or in breastfeeding period;
14. Patients doing medication or receiving prohibited treatments;
15. Patients with contraindication to perform MRI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks	Drug: Pramipexole; Oral medication, once a day during 16 weeks
Active Comparator: Control arm; Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up.	Drug: Risperidone; Oral medication, once a day during 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Clinical Academic Center (2CA-Braga)
• Collaborators: University of Minho

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Risperidone; Pramipexole
• Other Study ID Numbers: OCD-RT; 2022-000249-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No