NCT00004310Unknown2 期
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
National Center for Research Resources (NCRR)4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 1999年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 76
- 试验地点
- 4
研究概览
简要总结
OBJECTIVES:
I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI) followed by a 12-week course of maintenance therapy in patients with obsessive compulsive disorder.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by participating institution. Patients are randomized into one of two treatment arms.
Arm I: Patients receive a pulse loading dose of clomipramine (CMI) IV and an oral placebo on days 1 and 2.
Arm II: Patients receive an oral pulse loading dose of CMI and an IV placebo on days 1 and 2.
Patients receive maintenance therapy with daily oral CMI for 12 weeks beginning 4 days after pulse loading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics-- Primary diagnosis of obsessive compulsive disorder (OCD) for at least 1 year Meets Diagnostic and Statistical Manual (DSM-IV) criteria by structured clinical interview Yale-Brown Obsessive-Compulsive Scale (YBOCS) score at least 20 At least 12 if only obsessions or compulsions present Secondary diagnosis of major depression eligible if: Meets DSM-IV criteria Onset occurs after OCD OCD is primary diagnosis and dominates clinical picture Excluded diagnoses: Organic mental disorder Principal psychiatric disorder other than OCD Bipolar disorder Schizophrenia Post-traumatic stress disorder Tics or Tourette's syndrome Body dysmorphic disorder Delusional disorder Borderline or schizotypal personality disorder Anorexia nervosa Bulimia nervosa Panic disorder Panic attacks Must have failed at least 2 prior regimens of serotonin re-uptake inhibitor therapy --Prior/Concurrent Therapy-- Endocrine therapy: Concurrent thyroid medication allowed if stable at least 3 months At least 2 weeks since prior systemic corticosteroids Surgery: No prior psychosurgery or other neurosurgery Other: At least 3 months since prior electroconvulsive or insulin shock therapy At least 6 weeks since prior fluoxetine At least 30 days since prior investigational drugs At least 2 weeks since any of the following: Neuroleptics (6 weeks since depot neuroleptics) Nondepot antipsychotics Anxiolytics Stimulants Barbiturates Antidepressants (4 weeks since monoamine oxidase inhibitors) At least 2 weeks since prior anticonvulsants No concurrent antipsychotics No concurrent antihypertensives, e.g., guanethidine or clonidine No concurrent behavior therapy --Patient Characteristics-- Hematopoietic: No anemia No drug-induced leukopenia No bleeding disorder No other blood dyscrasia or bone marrow depression Hepatic: Liver function tests no greater than twice normal No hepatic abnormality Renal: No renal abnormality, e.g., urinary retention Cardiovascular: No cardiac abnormality, e.g.: Congestive heart failure Myocardial infarction Cardiac conduction disturbance other than first-degree heart block Electrocardiogram with significant abnormality No hypertension Pulmonary: No pulmonary abnormality Other: No hypersensitivity to or prior severe adverse experience with clomipramine No medical contraindication to serotonin re-uptake inhibitors or tricyclic antidepressants No history of seizures and not at risk of seizures, i.e.: No family history of epilepsy No birth trauma No significant head trauma No meningitis or encephalitis No subarachnoid hemorrhage No episodes of unconsciousness, including syncope No prostatic hypertrophy No narrow-angle glaucoma, i.e., intraocular pressure greater than 22 mm Hg No uncontrolled hyperthyroidism No other clinically significant abnormality, e.g.: Neurologic Metabolic Gastrointestinal Autoimmune No substantial risk of suicide At least 6 months since drug or alcohol abuse or dependence No illiteracy No Intelligence Quotient below 80 No plan for blood donation during study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
排除标准
- 未提供
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Study of Debio 1450 for Bacterial Skin InfectionsBacterial InfectionsNCT02426918Debiopharm International SA330
已完成
2 期
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute PyelonephritisAcute PyelonephritisNCT03757234Paratek Pharmaceuticals Inc201
已完成
2 期
A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)Sickle Cell DiseaseNCT05075824Hoffmann-La Roche95
已完成
3 期
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal AnemiaAnemiaNCT00605293Hoffmann-La Roche101
终止
2 期
A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic CancerCutaneous Squamous Cell CarcinomaTriple Negative Breast CancerOropharynx Squamous Cell CarcinomaNon-Small Cell Lung CancerMerkel Cell CarcinomaBasal Cell CarcinomaNCT04916002Regeneron Pharmaceuticals77