Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
|ClinicalTrials.gov Identifier: NCT00004310|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||October 18, 1999|
|First Posted Date ICMJE||October 19, 1999|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||October 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder|
|Official Title ICMJE||Not Provided|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Obsessive-Compulsive Disorder|
|Intervention ICMJE||Drug: Clomipramine|
|Study Arms||Not Provided|
|Publications *||Koran LM, Sallee FR, Pallanti S. Rapid benefit of intravenous pulse loading of clomipramine in obsessive-compulsive disorder. Am J Psychiatry. 1997 Mar;154(3):396-401.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004310|
|Other Study ID Numbers ICMJE||199/11812
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Research Resources (NCRR)|
|Collaborators ICMJE||Stanford University|
|PRS Account||National Center for Research Resources (NCRR)|
|Verification Date||December 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP