Obsessive-Compulsive DisorderPhase 2OCD-RTNCT05401019
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
A Phase 2 study testing Pramipexole and Risperidone in people with Obsessive-Compulsive Disorder, run by Clinical Academic Center (2CA-Braga).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Pramipexole and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
About this study
Official title: 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).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Pramipexole, Risperidone
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Oral medication, once a day during 16 weeks
RisperidoneDrug
Oral medication, once a day during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks Receives: Drug: Pramipexole |
| Control arm | Active comparator | Treatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Y-BOCS total score at visit 9 (16 weeks)
Secondary outcomes (8)
Safety outcomes
Number of adverse events
Measured: Change from Baseline at visit 9 (16 weeks)
Biochemical parameters
Complete blood count, cortisol, adrenocorticotropic hormone, thyroxine and thyroid stimulating hormone values
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Change from Baseline at visit 9 (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: This clinical trial was not approved by the regulatory entities. It was reviewed and a new trial was re-submitted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minho
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401019
- Sponsor's protocol ID
- OCD-RT
- Other IDs
- 2022-000249-34
- Acronym
- OCD-RT
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05401019
- Acronym / sponsor ID
- OCD-RT / OCD-RT
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This clinical trial was not approved by the regulatory entities. It was reviewed and a new trial was re-submitted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Collaborators
- University of Minho
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: PramipexoleTreatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks |
| Control arm | Active comparator | Drug: RisperidoneTreatment with Risperidone, once a day, tablet of 0.5, 1, 1.5, 2 mg per day during 16 weeks + 8 weeks follow-up. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PramipexoleOral medication, once a day during 16 weeks | Drug | Experimental arm |
| RisperidoneOral medication, once a day during 16 weeks | Drug | Control arm |
Primary outcome
Y-BOCS total score
Time frame: 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
8 secondary outcomes
Safety outcomes
Time frame: Change from Baseline at visit 9 (16 weeks)
Biochemical parameters
Time frame: Change from Baseline at visit 9 (16 weeks)
Neurobiological parameters
Time frame: Change from Baseline at visit 9 (16 weeks)
Scores of the 4 subscales of the WHOQOL-bref
Time frame: Change from Baseline at visit 9 (16 weeks)
OCI-R Total score
Time frame: Change from Baseline at visit 9 (16 weeks)
PSS-10 Total score
Time frame: Change from Baseline at visit 9 (16 weeks)
HAM-A Total score
Time frame: Change from Baseline at visit 9 (16 weeks)
HAM-D Total score
Time frame: Change from Baseline at visit 9 (16 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pramipexole and Risperidone in people with Obsessive-Compulsive Disorder, run by Clinical Academic Center (2CA-Braga).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y-BOCS total score (time frame: Change from Baseline Y-BOCS total score at visit 9 (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.