Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD) - Clinical Trial for Obsessive-Compulsive Disorder | NCT05401019

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Pramipexole

Risperidone

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Control arm

Arm Description

Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks

Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety outcomes

Number of adverse events

Biochemical parameters

Complete blood count, cortisol, adrenocorticotropic hormone, thyroxine and thyroid stimulating hormone values

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

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).

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.

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.

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).

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.

Full Information

NCT ID

NCT05401019

First Posted

May 25, 2022

Last Updated

May 27, 2022

Sponsor

Clinical Academic Center (2CA-Braga)

Collaborators

University of Minho

1. Study Identification

Unique Protocol Identification Number

NCT05401019

Brief Title

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

Acronym

OCD-RT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinical Academic Center (2CA-Braga)

Collaborators

University of Minho

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up.

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Intervention Description

Oral medication, once a day during 16 weeks

Intervention Type

Drug

Intervention Name(s)

Risperidone

Intervention Description

Oral medication, once a day during 16 weeks

Primary Outcome Measure Information:

Title

Y-BOCS total score

Description

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

Time Frame

Change from Baseline Y-BOCS total score at visit 9 (16 weeks)

Secondary Outcome Measure Information:

Title

Safety outcomes

Description

Number of adverse events

Time Frame