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Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder Clinical research trials and Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder. Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder clinical trial. Subjects frequently get the best healthcare possible for their Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder  Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
For Condition: Obsessive-Compulsive Disorder
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Stanford University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 76
Location and Contact Information:
Overall Study Official:
LorrinKoran, Study Chair, Stanford University
Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5408
United States
Recruiting Lorrin Koran 650-723-5154
University of Cincinnati Medical Center *Recruiting*
Cincinnati, Ohio, 45267-0562
United States
Recruiting Floyd Sallee 513-636-4414
Additional Information:
Study ID Numbers: 199/11812; SUMC-36784
Study Start Date: October 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004310
Other Obsessive-Compulsive Disorder Studies:
1. Characterization of Childhood-Onset Obsessive-Compulsive Disorder
2. Treatment for Anxiety in Children
3. Behavior Therapy for Children and Adolescents with Obsessive-Compulsive Disorder (OCD)
4. Treatment of Obsessive-Compulsive Disorder
5. Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
Related Studies:
Other Obsessive-Compulsive Disorder Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
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