The Stanley Medical Research Institute

Summaries of Approved Treatment Trial Grants from the October 2003 Submissions

Galila Agam, Ph.D.  

Yuly Bersudsky, M.D., Ph.D.

Ben Gurion University                                            

Beersheva, Israel

A five week, double-blind, randomized study of vanoctamide in the treatment of bipolar mania or schizoaffective disorder, manic type.  Vanoctamide is similar to valproic acid but has lower potential for teratogenicity.

 

S. Paul Berger, M.D., et al.

Portland Veterans Affairs Medical Center

Portland, OR

A 10 week, double-blind trial of epigallocatechin gallate (EGCG) added to antipsychotics for the treatment of 40 patients with schizophrenia.  The study seeks to determine if this constituent of green tea, which preclinical studies suggest inhibits nitrous oxide synthetase, will be of benefit as an adjunct in the treatment of schizophrenia.

 

E. Sherwood Brown, M.D., Ph.D.

Laura Beard, M.D.

UT Southwestern Medical Center at Dallas

Dallas, TX

A 12 week, double-blind placebo-controlled trial of adjunctive citicoline (cytidine-5-diphosphocholine) therapy in patients with a history of mania or hypomania and cocaine abuse/dependence. Citicoline, a putative neuroprotective and antidepressant agent will be tested for potential mood stabilizing, cognitive enhancing and anti-craving effects in this population.

 

Kadiamada Roy N. Chengappa, M.D.

Western Psychiatric Institute and Clinic

Pittsburgh, PA

L-Carnosine, a naturally occurring antioxidant and anti-glycosylation agent will be tested for cognitive enhancement among 70 persons with schizophrenia in an 18 week randomized, double-blind, placebo controlled, clinical trial.

 

Jayashri Kulkarni, Ph.D., M.B.B.S., M.P.M., F.R.A.N.Z.C.P., et al.

The Alfred Hospital/Monash University

Victoria, Australia

28 day, double-blind, placebo-controlled, randomized trial of lithium plus either tamoxifen, placebo or progesterone in 60 female patients with bipolar disorder, manic phase.  This study seeks to determine if putative antimanic effects of tamoxifen are due to protein kinase C inhibitions, or estrogen antagonism.

 

Jayashri Kulkarni, Ph.D., M.B.B.S., M.P.M., F.R.A.N.Z.C.P., et al.

The Alfred Hospital/Monash University

Victoria, Australia

Three month double-blind, randomized, three arm comparison of the effects of  olanzapine plus adjunctive raloxifene, estradiol 2mg plus dyhydroprogesterone or  placebo in 60 post-menopausal women with schizophrenia. The study aims to compare the effects of two adjunctive estrogen treatment strategies on psychopathology, cognition and side effect burden.

 

Colin P. O’Donnell, M.B., B.Ch., B.A.O., M.R.C.Psych., et al.

University of Melbourne

Victoria, Australia

A double-blind randomized placebo-controlled adjunctive study of vitamin B12, folic acid, and pyridoxine to antipsychotic/mood stabilizer treatment in 120 patients with first episode psychosis. The study seeks to determine if these vitamins have neuroprotective and cognitive enhancing effects early in the course of schizophrenia.


Jennifer L. Payne, M.D.

Johns Hopkins

Baltimore, MD

Eight week, double-blind, placebo controlled trial of riluzole, a glutamate antagonist, in 94 patients with bipolar depression. Riluzole is a neuroprotective agent used to treat amyotrophic lateral sclerosis. 

 

Carol Tamminga, M.D., et al.

UT Southwestern Medical Center

Dallas, TX

Two site, randomized, sixteen week study to generate functional imaging data of potential predictors of response to lithium or lamotrigine monotherapy for acute treatment of depression in 20 patients with bipolar II disorder.

 

Gang Wang, M.D., Ph.D., et al.

Beijing Anding Hospital, Capital University of Medical Sciences

Beijing, China

60 week, randomized, double-blind, placebo-controlled trial of valproate added to risperidone in 200 treatment-naïve, first-episode patients with schizophrenia.

 

Mark Weiser, M.D., et al.

Sheba Medical Center

Tel Hashomer, Israel

A 16 week, double-blind, parallel group, placebo-controlled trial of D-serine as an adjunct to antipsychotic treatment in 200 schizophrenic patients with persistent negative and cognitive symptoms of schizophrenia.

 

O Wuliji, M.D., et al.

Shengton Research Institute of the Traditional Mongolian Medicine

Autonomous Region, China

Eight week double-blind, placebo-controlled, randomized, trial of the traditional Mongolian medical prescription Shuangzao mixture added to sulpiride in 200 patients with schizophrenia. Principal ingredients include fructose choerospondiatis and semen ziziphi spinosae.

 

Allan H. Young, Ph.D., M.Phil., M.B., Ch.B., et al.

University of Newcastle

Newcastle upon Tyne, United Kingdom

Placebo-controlled parallel group design study of adjunctive mifepristone (RU-486), aglucocortiroid receptor antagonist in the treatment of 150 patients with bipolar depression.

 

Xiang Y. Zhang, M.D., Ph.D., et al.

Beijing Hui-Long-Guan Hospital

Beijing, P.R. China

A 24 week double-blind, placebo-controlled trial of the anti-inflammatory drug celecoxib added to risperidone in 250 treatment-naive, first-episode patients with schizophrenia.