Boston, Massachusetts 02114


Purpose:

The purpose of this study is to find out more about how the brain stores emotional learning in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human beings learn not to fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. We hope this study will help us understand why people with OCD cannot control unwanted fear and to develop better treatments for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive 12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking right-handed individuals 18-60 with OCD and individuals with no psychiatric history. Participation includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT, questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your participation and reimbursement for parking.


Criteria:

Inclusion Criteria: - Outpatient men and women age 18 to 60, proficient in English, and able to give informed consent - For OCD patients only: Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score > 16) - Right-handed (Edinburgh Handedness Inventory total score ≥ 70) Exclusion Criteria: - Current clinically significant suicidality and/or BDI-II suicide item (#9) score >1 - Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in BT - Psychopathology not appropriate for the treatment (such as substance abuse or dependence within the past 3 months; current manic episode; psychosis) - Previous treatment with ≥4 sessions of BT for OCD - Currently receiving any other psychotherapy or planning to initiate such treatment during the study - Use of conventional antipsychotic medications or medications that would lower seizure threshold in high doses or may otherwise affect cerebral metabolism (other than to those required for stabilization of OCD). - Use of benzodiazepines within 2 weeks prior to study is not allowed. Use of other psychotropic medications (e.g., SSRIs and atypical antipsychotics) will be allowed provided the dose has been stable for > 8 weeks. Planning on initiation or dose change of psychotropic medication during the study. - Impaired (or uncorrected) vision, medical illness, or medical treatment that would likely interfere with participation. - History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae; History of seizures; History of stroke; Signs of increased intracranial pressure; Prior neurosurgical procedure - Metal in the body, metal injury to the eyes; Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt - Pregnancy; breastfeeding or nursing; if the patient cannot rule out the possibility of pregnancy, a pregnancy test (to be ruled out by urine ß-HCG) will be conducted prior to study - Weight > 250 lbs


NCT ID:

NCT02467374


Primary Contact:

Principal Investigator
Sabine Wilhelm, Ph.D.
Massachusetts General Hospital: Department of Psychiatry

Valerie Braddick, BA
Phone: 617-724-4354
Email: vbraddick@mgh.harvard.edu


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States

Valerie Braddick, BA
Phone: 617-724-4354
Email: vbraddick@mgh.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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