Safety and Efficacy of Pramipexole Treatment in Resistant Obsessive-Compulsive Disorder (OCD): Pilot, Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference between baseline and after treatment in Y-BOCS total score
研究概览
简要总结
The most common and effective treatment for OCD is pharmacological therapy that includes selective serotonin reuptake inhibitors (SSRIs) antidepressants and, in the case of patients resistant to this approach, a combination with antipsychotics. Risperidone and aripiprazole are atypical antipsychotics that act on dopamine (D2) and serotonin receptors. Studies have shown that these drugs are effective in boosting SSRIs for the treatment of OCD in resistant patients.
Currently a high percentage of people diagnosed with OCD do not respond to the existing treatments. Pramipexole is a dopaminergic receptor agonist that specifically binds to dopamine D2 and D3 receptors, having demonstrated benefit in resistant depression.
The aim of this clinical trial is to explore how pramipexole can act in the treatment of OCD in resistant patients, evaluating its safety and efficacy.
详细描述
Phase 2 clinical trial, randomized, with three-parallel-groups, lasting 26 weeks (screening phase, 4 weeks + treatment phase, 16 weeks + follow-up phase, 6 weeks), whose primary objective is to evaluate the effectiveness of using pramipexole as a strategy for boosting SSRIs, in three different doses, in treatment of resistant OCD.
The main endpoint is the measurement of the difference in the total score of the Y-BOCS scale between baseline (V1; before intervention with the investigational drug) and week 16 (V9; after intervention with the investigational drug), between the different groups treated with different doses of pramipexole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 resistant to the first-line treatment for OCD:
- •5.1 Patients who do not respond to treatment with at least two selective serotonin reuptake inhibitor antidepressants (SSRIs) at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with SSRIs.
- •5.2 Patients who do not respond to treatment with risperidone or aripiprazole as potentiation of the SSRIs at the maximum tolerated therapeutic dose during at least 12 weeks, i.e. patients in whom there is no reduction in the Y-BOCS score by 25% relative to the score obtained before starting treatment with the antipsychotic or patients in whom the Y-BOCS score is kept ≥ 16 after the treatment with the antipsychotic.
排除标准
- •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 who are doing or have done psychotherapy in the last 6 months;
- •Patients doing medication or receiving prohibited treatments;
- •Patients with allergy to pramipexole or any of the excipients;
- •Patients with creatinine clearance ≤ 50 ml/min (calculated by Cockcroft-Gault formula);
- •Patients with NYHA III or IV heart failure or any other severe cardiovascular disease;
- •Hypotension (<90/60 mmHg) sitting position and hypotension orthostatic (drop in systolic AT ≥20 mmHg or diastolic AT ≥10 mmHg after 2-3 minutes of orthostatism) at the screening;
- •Patients with contraindication to perform MRI cannot participate in the assessment of the exploratory endpoint (i.e., other pre-specified outcomes).
研究组 & 干预措施
Pramipexole at a dose of 0.088 mg/tid
Treatment with antidepressant and pramipexole at a dose of 0.088 mg/tid (0.125 mg of salt)
干预措施: Pramipexole 0.088mg/tid (Drug)
Pramipexole at a dose of 0.18 mg/tid
Treatment with antidepressant and pramipexole at a dose of 0.18 mg/tid (0.25 mg of salt)
干预措施: Pramipexole 0.18 mg/tid (Drug)
Pramipexole at a dose of 0.35 mg/tid
Treatment with antidepressant and pramipexole at a dose of 0.35 mg/tid (0.50 mg of salt)
干预措施: Pramipexole 0.35 mg/tid (Drug)
结局指标
主要结局
Difference between baseline and after treatment in Y-BOCS total score
时间窗: Baseline and Week 16
The measurement of the difference in the total score of the Y-BOCS scale between baseline (before intervention with the investigational drug) and after intervention with the investigational drug, between the different groups treated with different doses of pramipexole. 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. The final scores range from 0 to 40, with higher scores indicating higher symptom severity. The scores indicate subclinic (0 - 7 points), mild (8 - 15 points), moderate (16 - 23 points), severe (24 - 31 points), and extreme severity (32 - 40 points).
次要结局
- Number of adverse events observed(From Day 2 (after the first dose of the investigational drug) until Week 22 (end of study))