Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stanford University
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004310
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: Clomipramine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 76
Study Start Date: October 1999
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004310

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0562
Sponsors and Collaborators
Stanford University
Investigators
Study Chair: Lorrin Koran Stanford University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004310     History of Changes
Other Study ID Numbers: 199/11812, SUMC-36784
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
anxiety disorder
disease-related problem/condition
neurologic and psychiatric disorders
obsessive compulsive disorder
oncologic disorders
rare disease

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Clomipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014