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

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