clinical research

Treatment of Negative Symptoms and Social Dysfunction in Schizophrenia with Repetitive Transcranial Magnetic Stimulation (rTMS)

Purpose of the Study

• To test whether repetitive transcranial magnetic stimulation (rTMS) is effective as an augmentation treatment of negative symptoms and social deficits of schizophrenia resistant to conventional treatments.

Study Design

The study is conducted in 2 Phases:

• Phase 1: Placebo controlled single-blind trial (4 weeks of daily treatment)
• Phase 2: Cross-over to open label active treatment (4 weeks of daily treatment)
• Follow up: Naturalistic 2-month follow-up

Design Features

• Patients who received sham in Phase 1 and failed to respond, and patients who received active or sham in Phase 1 but had only a partial response will be given the option of receiving 4 weeks of open active rTMS (Phase 2).
• Patients who meet response criteria in either the randomized phase or the cross-over phase will enter the Follow up during which time they will continue routine care under your supervision, and will be invited back for a repeat assessment monthly for 2 months to determine the persistence of benefit.

Clinical Management During the Study

• To participate in this study, your patient needs to be stable symptom-wise, without change in antipsychotic medication for at least 4 weeks or at least 2 weeks for any other psychotropic agents (e.g. antidepressants).
• Should your patient’s clinical condition deteriorate such that it would not be wise for him/her to continue in the study, we will withdraw him/her from the study at that point and notify you immediately. Whether the withdrawal from the study was made for clinical reasons by the research team, or by the patient for other reasons, the patient would receive treatment recommendations, and return to routine clinical management under your supervision.

For Further Information

• If you have any questions about this study, you can contact the Principal Investigator, Dr. Arielle Stanford, at 212-543-6230 or the study coordinator at 212-543-5767.