MENTAL HEALTH
A Placebo-Controlled Clinical Trial of a Stan-
dardized Extract of Hypericum perforatum in
Major Depressive Disorder (Jonathan David-
son, MD, Duke University) Cofunded with the National
Institute of Mental Health and the Office of Dietary Sup-
plements—The purpose of this multisite, Phase III
trial is to study the acute efficacy and safety of a
standardized extract of Hypericum perforatumin the
treatment of patients with major depression. This
three-arm, double-blind clinical efficacy study will
compare a standardized extract of Hypericum to
placebo over an eight-week period. Subjects
responding to treatment will be followed for an
additional four months. A third treatment group,
using a selective serotonin reuptake inhibitor, will be
included to ensure the validity of the trial.
Acupuncture in the Treatment of Depression
(John Allen, PhD, University of Arizona)—This
randomized, double-blind, placebo-controlled
Phase III trial is testing the efficacy of acupuncture
to treat major depression. The study is unique in
that treatment effects will be assessed from the per-
spectives of both western psychiatry and Chinese
medicine.
Method for Making an Improved St. John‘s
Wort Product (Trevor P. Castor, PhD, Aphios
Corp.)—The project seeks to develop an improved
St. John’s wort product that can be manufactured
in a standardized and reproducible manner and in
strict accordance with current Good Manufacturing
Practices of the Food and Drug Administration.
Omega-3 Fatty Acids in Bipolar Disorder
Prophylaxis (Andrew Stoll, MD, McLean Hospi-
tal) Cofunded with the National Institute of Mental
Health—The purpose of this Phase III clinical trial is
to assess the efficacy of omega-3 fatty acids in pre-
venting recurrence in patients with bipolar disor-
der, type I. One hundred and twenty outpatients
with bipolar disorder, type I, will be randomly
assigned to receive add-on treatment with omega-
3 fatty acids or placebo, for one year. The primary
goal is to assess the prophylactic effects of omega-3
fatty acids in a cohort of bipolar patients with a rel-
atively high risk of recurrence.
Oxidative Cell Injury in First Episode Psy-
chotic Patients (Sahebarao Mahadik, PhD,
Medical College of Georgia)—This project seeks to
establish that increased oxidative cell injury exists
at the onset of psychosis and that probably contin-
ued injury contributes to deteriorating course of ill-
ness in some patients. Results from this study could
provide a mechanism by which dietary antioxi-
dants might reduce some abnormal pathologies
leading to psychosis.MUSCULOSKELETAL DISORDERS
Efficacy of Acupuncture in the Treatment of
Fibromyalgia (Dedra A. Buchwald, MD, Uni-
versity of Washington )—Ninety-six patients with
fibromyalgia will be recruited for a 12-week, 24-
treatment,3-arm, randomized, controlled Phase II
clinical trial. The active treatment group will
receive true acupuncture. Control groups will be
treated with acupuncture for an unrelated condi-
tion. These patients will receive needle insertion at
nonchannel, nonpoint locations, or a true placebo.
Short-and long-term efficacy and side effects will
be measured using both subjective and objective
measures of overall health and pain, to determine
the optimal duration of treatment and examine the
concordance of allopathic and acupuncture-based
measures of outcome.
Evaluating the Efficacy of Acupuncture for
Back Pain (Daniel Cherkin, DrPH, Center for
Health Studies, Seattle,Washington) Cofunded with
the Agency for Healthcare Research and Quality—The
goals of this Phase II study are (1) to develop and
evaluate methods for improving randomized trials
to assess the efficacy of acupuncture,and (2) to use
this information to design and pilot-test a random-
ized clinical trial of acupuncture for persistent low
back pain. The trial will compare acupuncture to
standard medical care, and standardized to individ-
ualized acupuncture treatment.
Pilot Study of Acupuncture in Fibromyalgia
(Daniel J. Claw, MD, Georgetown University Med-
ical Center)—A randomized, blinded, sham-con-
trolled, 2-by-2 factorial Phase II trial will be
conducted to examine the individual and synergistic
effects of needle placement and stimulation on the
efficacy of acupuncture as a therapeutic modality in
fibromyalgia. The design allows determination of
dose-effect for the analgesic effect of acupuncture.
Trial of Acupuncture for Carpal Tunnel
Syndrome (Arthur Weinstein, MD, GeorgeAppendix V 233