Lorrin Koran
Dextro-Amphetamine versus Caffeine in Treatment-resistant OCD
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for OCD, and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: dextro-amphetamine
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 55 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
:
- outpatient age 18 through 55 inclusive
- DSM-IV criteria for obsessive-compulsive disorder (OCD)with YBOCS greater
than or equal to 20
- provide written informed consent
- no serious or unstable medical disorder, including no hypertension
or cardiac disease
- not intending to receive psychotherapy for OCD during the study
- taking therapeutic dose of SSRI, venlafaxine, duloxetine, or
clomipramine for at least 12 weeks
- if taking buspar, gabapentin, an atypical antipsychotic, or
a benzodiazepine, dose has been stable for 4 weeks
- negative urine drug and pregnancy tests
Key Exclusion Criteria:
- pregnant, breastfeeding, not practicing reliable birth control method
- blood pressure readings greater than 140 mm Hg systolic or
90 mm Hg diastolic at screen, or history of hypertension, whether or
not it is controlled by medication
- hoarding is primary or only OCD symptom
- history of myocardial infarction or cardiac arrhythmia
- weight less than 100 lbs at screen
- requiring psychotropic medications other than an SRI, a
benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
- taking medication that inhibits hepatic enzyme CYP1a2 (e.g. Cipro)
- taking an MAO inhibitor
- comorbid tics or Tourette's disorder
- history of panic disorder
- history of glaucoma
- history of seizures
- schizophrenia or psychotic disorder, schizotypal personality disorder
- any depression with current suicide risk
- mental retardation, PDD, or cognitive disorder
- factitious disorders
- current or past cyclothymic disorder or bipolar disorder
- dissociative disorders
- personality disorder sufficient to interfere with study participation
- organic mental disorder or dementia
- current or past substance abuse / dependence (excluding nicotine)
- current or past anorexia or bulimia
- receiving psychotherapy for OCD
- had a previous trial of d-amphetamine of at least 30 days
- unable to speak, read, or understand English or unlikely to
follow study procedures
- not suitable for study in investigator's opinion
Additional Study Details
Official Title:
Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine versus Caffeine Augmentation in Treatment Resistant OCDAnticipated start date:
8/1/2006Lead Sponsor:
Stanford UniversityCollaborator(s):
- Obsessive-Compulsive Foundation, Inc.
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
UnspecifiedPrimary Outcomes:
- Clinical Global Impressions Scale - Improvement
- Yale-Brown Obsessive-Compulsive Scale
Total Number to be Enrolled:
24Total Number to be Enrolled at Stanford:
24More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/25/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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