Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to qualify for enrollment into
the study:

1. All subjects will be 18 - 65 years of age.

2. Obsessive-compulsive disorder:

- Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive

- Y-BOCS total score > 16

3. Subjects are willing and able to adhere to the intensive treatment schedule and all
required study visits.

Exclusion Criteria

Subjects will be excluded from study participation if one of the following exclusion
criteria applies:

1. Subjects are unable or unwilling to give informed consent.

2. No exclusion criteria for comorbid DSM diagnosis.

3. Subjects with a clinically defined neurological disorder that caused significant
safety concern to receive TMS treatment, including, but not limited to:

- Any condition likely to be associated with increased intracranial pressure.

- Space occupying brain lesion.

- Any history of seizure EXCEPT those therapeutically induced by ECT (childhood
febrile seizures are acceptable and these subjects may be included in the
study).

- History of stroke.

- Transient ischemic attack within two years.

- Cerebral aneurysm.

- Dementia.

- Mini Mental Status Exam (MMSE-2) score of <24.

- Parkinson's disease.

- Huntington's disease.

- Multiple sclerosis.

- Increased risk of seizure for any reason, including prior diagnosis of increased
intracranial pressure (such as after large infarctions or trauma), or currently
taking medication that lowers the seizure threshold. Medications that lower the
seizure threshold are included in the Prohibited Concomitant Medication (Section
5.8).

4. Subjects with any of the following treatment histories:

- TMS treatment within 6 months prior to the screening visit.

- Lifetime history of treatment with Deep Brain Stimulation

- Use of any investigational drug or device within 4 weeks of the randomization
visit.

- If participating in psychotherapy, must have been in stable treatment for at
least 2 months prior to entry into the study, with no anticipation of change in
the frequency of therapeutic sessions, or the therapeutic focus over the
duration of the trial.

- Recent 2-month medication changes

5. Contraindication to receive TMS:

- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute,
unstable cardiac disease.

- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear
implants, stents, or electrodes) or any other metal object within or near the
head, excluding the mouth, which cannot be safely removed.

- Clinically significant abnormality or clinically significant unstable medical
condition, as indicated by medical history, physical examination, ECG results,
or clinical laboratory testing, that in the Investigator's judgment might pose a
potential safety risk to the subject or limit interpretation of the trial
results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary
and renal malfunctioning.

6. Women who are currently pregnant or not using a medically acceptable means of birth
control and women who are breastfeeding.