Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder
Information source: National Center for Research Resources (NCRR)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: Clomipramine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s): Lorrin Koran, Study Chair, Affiliation: Stanford University
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Stanford University Medical Center, Stanford, California 94305-5408, United States
University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0562, United States
Additional Information
Related 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.
Starting date: October 1999
Last updated: June 23, 2005
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