Complementary and alternative therapies for psychiatric disorders are increasingly popular despite the lack of rigorous scientific data addressing their safety, tolerability, or efficacy. The proposed study adds to a small but growing body of literature to evaluate acupuncture in the treatment of mood disorders. The primary aims are to evaluate the feasibility and efficacy of acupuncture treatment in conjunction with psychopharmacology alone. The study will replicate methods of acupuncture diagnosis and treatment designed in a previous NIMH- funded study. The role of subjects' expectancies for acupuncture treatment will be evaluated. Patients will be randomized to either acupuncture plus stable medications (ACUP N=15) on clinical outcome or non-specific acupuncture plus stable medications (NS ACUP N=15). Clinical contact with an acupuncturist will be equivalent for both groups (12 sessions, 8 weeks). Patients, raters, and psychiatrists will be blind to group assignment. The criteria for inclusion now require moderate (vs. mild) depression for study entry to minimize study confounds such as spontaneous improvement. Safety measures and procedures to maintain study retention have been strengthened. Acupuncture patients will meet weekly with an RA and psychiatrist to complete ratings (IDS-C, CGI-BP, YMRS, GAF) and to assess side effects and symptom severity. We will include a comparison group (TAU) of patients who met entry criteria but refused the acupuncture intervention. Those subjects will continue to receive pharmacological treatment, and retrospective chart audit will allow us to determine the degree of change expected from medication treatment alone in this sample. While clinical trials have addressed the efficacy of acupuncture treatment for unipolar depression, a unique opportunity exists to bring similar rigor to the study of acupuncture for depressive symptoms in bipolar disorder. A strength of this proposal is its replication of methodology developed and used by other researchers in a study of acupuncture in MDD. Should acupuncture demonstrate efficacy in the treatment of bipolar disorder, further studies will be proposed to evaluate its utility for maintenance and prevention.
Dennehy, Ellen B; Schnyer, Rosa; Bernstein, Ira H et al. (2009) The safety, acceptability, and effectiveness of acupuncture as an adjunctive treatment for acute symptoms in bipolar disorder. J Clin Psychiatry 70:897-905 |