Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD): Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- Y-BOCS total score
研究概览
简要总结
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).
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
- Single (Investigator)
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 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).
排除标准
- •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.
研究组 & 干预措施
Experimental arm
Treatment with pramipexol, once a day, tablet of 0.088, 0.18, 0.35, 0.53 mg per day during 16 weeks
干预措施: Pramipexole (Drug)
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.
干预措施: Risperidone (Drug)
结局指标
主要结局
Y-BOCS total score
时间窗: 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
次要结局
- Biochemical parameters(Change from Baseline at visit 9 (16 weeks))
- Neurobiological parameters(Change from Baseline at visit 9 (16 weeks))
- Scores of the 4 subscales of the WHOQOL-bref(Change from Baseline at visit 9 (16 weeks))
- OCI-R Total score(Change from Baseline at visit 9 (16 weeks))
- PSS-10 Total score(Change from Baseline at visit 9 (16 weeks))
- Safety outcomes(Change from Baseline at visit 9 (16 weeks))
- HAM-A Total score(Change from Baseline at visit 9 (16 weeks))
- HAM-D Total score(Change from Baseline at visit 9 (16 weeks))