Study on Pramipexole for Patients with Resistant Obsessive-Compulsive Disorder (OCD)

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What is this study about?

This clinical trial is focused on studying the treatment of Obsessive-Compulsive Disorder (OCD), a mental health condition characterized by unwanted and repeated thoughts, feelings, ideas, or sensations (obsessions) that drive individuals to do something repetitively (compulsions). The study will use a medication called Pramipexole, which is being tested in different doses to see if it can help improve symptoms in people whose OCD has not responded well to standard treatments. Pramipexole is taken in the form of tablets and is already used for other conditions, but this study aims to see how effective it is for OCD.

The purpose of the study is to evaluate the effectiveness of using Pramipexole as an additional treatment to boost the effects of medications known as SSRIs, which are commonly used to treat OCD. Participants in the study will receive one of three different doses of Pramipexole or a placebo. The study will last for several weeks, during which participants will take the medication and attend regular check-ups to monitor their progress and any side effects.

Throughout the study, researchers will assess changes in the severity of OCD symptoms using a specific scale designed to measure these symptoms. They will also keep track of any side effects experienced by participants. The study aims to provide valuable information on whether Pramipexole can be a helpful treatment option for people with OCD who have not found relief with other medications.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of obsessive-compulsive disorder (OCD) and ensuring previous treatment resistance.

Eligibility criteria include age between 18 and 64 years, European Portuguese as the mother tongue, and a score of 16 or higher on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).

2 baseline evaluation

A baseline evaluation is performed to record the initial Y-BOCS score before starting the investigational drug. This serves as a reference point for future assessments.

3 medication administration

The investigational drug, pramipexole, is administered orally in tablet form. The study involves three different doses: 0.35 mg, 0.088 mg, and 0.18 mg.

The medication is taken as prescribed, with the specific dosage and frequency determined by the study protocol.

4 ongoing monitoring

Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes tracking changes in the Y-BOCS score and recording any adverse events.

Monitoring continues from the first dose until the end of the study period, which is estimated to conclude by December 31, 2028.

5 final assessment

A final assessment is conducted at week 16 to evaluate the difference in the Y-BOCS score from the baseline. This helps determine the effectiveness of the pramipexole treatment.

The study also records the number of adverse events observed throughout the trial, categorized by their seriousness and relation to the investigational drug.

Who Can Join the Study?

Patients must have been diagnosed with Obsessive-Compulsive Disorder (OCD) according to specific guidelines known as DSM-5 and/or ICD-10.
Patients should be between 18 and 64 years old.
Patients must speak European Portuguese as their first language.
Patients need to have a score of 16 or higher on a test called the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), which measures the severity of OCD symptoms.
Patients must have shown resistance to initial treatments for OCD. This means they did not respond well to at least two types of medications called Selective Serotonin Reuptake Inhibitors (SSRIs) at the highest dose they could handle for at least 12 weeks. The specific SSRIs include Fluoxetine, Fluvoxamine, Escitalopram, Citalopram, Paroxetine, and Sertraline. Resistance is defined as less than a 25% improvement in their Y-BOCS score or maintaining a score of 16 or higher after treatment.
Patients must also have shown resistance to additional treatment with medications called Risperidone or Aripiprazole, which are used alongside SSRIs, for at least 6 to 12 weeks. Resistance is defined similarly as less than a 25% improvement in their Y-BOCS score or maintaining a score of 16 or higher after treatment.
If patients are capable of having children, they must consistently and correctly use one of the approved birth control methods.

Who Cannot Join the Study?

Individuals who are not diagnosed with Obsessive-compulsive disorder (OCD) cannot participate.
Participants must be within the specified age range for the study.
Both males and females are eligible, but certain gender-specific conditions may exclude participation.
Participants should not belong to a vulnerable population, which means they should not be in a situation where they are unable to protect their own interests.
Individuals with other medical conditions that might interfere with the study or its results may be excluded.
Participants should not be taking medications that could conflict with the study treatment.
Pregnant or breastfeeding women may be excluded to avoid any potential risks to the baby.
Individuals with a history of severe allergic reactions to the study medication or similar drugs may be excluded.
Participants who are unable to comply with the study procedures or follow-up visits may be excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Recruiting	31.03.2024

Trial locations

Investigated drugs:

Pramipexole Dihydrochloride Monohydrate

Pramipexole is a medication being studied for its potential to help people with Obsessive-Compulsive Disorder (OCD) who have not responded well to other treatments. In this trial, it is being used to see if it can enhance the effects of medications known as SSRIs, which are commonly used to treat OCD. The goal is to determine if adding pramipexole can improve symptoms in patients who have resistant OCD.

Obsessive-compulsive disorder (OCD) – This is a mental health condition characterized by persistent, unwanted thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) that an individual feels driven to perform. These obsessions and compulsions can significantly interfere with daily activities and social interactions. The disorder often begins in childhood or adolescence and can vary in severity over time. People with OCD may recognize that their obsessions are not true, but the distress caused by these thoughts can lead to compulsive actions to alleviate anxiety. The condition can be chronic, with symptoms waxing and waning over time.

Trial ID:

2024-511085-37-00

Protocol code:

OCD-RT

Trial Phase:

Therapeutic exploratory (Phase II)

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