Pharmacotherapy of mental disorders has been developed for more than half century; however, the efficacy has been limited. Due to diversity of mental disorders, large and high-quality clinical trials are crucial to develop novel treatment strategies for mental disorders. Therefore, we set up a coordinative clinical-trial consortium“Taiwan Clinical Trial Consortium for Mental Disorders (CMD)”. The goals of this consortium are integrating research resources of mental disorders in Taiwan and assisting investigators in performing state-of-the-art, multi-center trials. Currently, our consortium integrates fifteen hospitals to conduct multi-center trials together. Moreover, our consortium had successfully finished an international trial transferred from clinical trial center in our hospital. Our consortium will continue to cooperate with it to promote clinical trials.

Aspect of international cooperation:

Our consortium is conducting five international multi-center clinical trials.

1. Cooperate with Merck (America) for a phase II trial related to the development of new drug for schizophrenia. (NCT: 04624243)
2. Cooperate with Sumitomo Dainippon Pharma (Japan) for a phase II/III trial related to the development of new drug for schizophrenia. (NCT: 04825860)
3. Cooperate with Boehringer Ingelheim (Germany) for a phase III trial related to the development of new drug for schizophrenia. (NCT: 04860830)
4. Cooperate with Boehringer Ingelheim (Germany) for a phase III extension trial related to the development of new drug for schizophrenia. (NCT: 05211947)
5. Cooperate with AbbVie (America) for a phase III trial related to the development of new drug for schizophrenia. (NCT: 05368558)
    

Aspect of industry/academia/research:

Our consortium is conducting three local multi-center clinical trials.

1. Cooperate with Excelsior Pharma for a phase II trial related to the development of new drug for schizophrenia.
2. Cooperate with Excelsior Pharma for a phase II trial related to the development of new drug for dementia.
3. Cooperate with BioLite Inc. for a phase II trial related to the development of new drug for adult patients with attention-deficit hyperactivity disorder.

Aspect of society and others:

1. In November 2022, PI, Dr. Hsien-Yuan Lane and the Co-PI, Dr. Chieh-Hsin Lin published a paper at Psychiatry and Clinical Neurosciences (SCI Impact Factor: 12.145). This is the first study to demonstrate that, by enhancing two vital endogenous antioxidants, catalase and glutathione, sodium benzoate therapy improved cognition of patients with Alzheimer's disease, with higher baseline catalase predicting better response.
2. In August 2022, Dr. Hsien-Yuan Lane and Dr. Chieh-Hsin Lin published a paper at International Journal of Neuropsychopharmacology (SCI Impact Factor: 5.678). This is the first study to indicate that sodium benzoate, but not sertraline (a commonly used serotonergic antidepressant), may improve cognitive function, attenuate perceived stress, and raise treatment adherence in patients with late-life depression.
3. In April 2021, Dr. Hsien-Yuan Lane and Dr. Chieh-Hsin Lin published a paper at JAMA Network Open (SCI Impact Factor: 13.366). This is the first study to show that an NMDA enhancer, herein benzoate, may improve cognitive function in women with behavioral and psychological symptoms of dementia.
4. In September 2018, Dr. Hsien-Yuan Lane and the Co-PIs, Dr. Chieh-Hsin Lin and Dr. Ching-Hua Lin published a paper at Biological Psychiatry (SCI Impact Factor: 12.81). This is the first study indicating that an NMDA modulator, herein a D-amino acid oxidase (DAAO or DAO) inhibitor, adjuvant therapy improved symptomatology of patients with most refractory schizophrenia, who have been treatment-resistant to the last-line therapy. The Editor of the Journal published Press Release and selected this article for Cover Art of the 2018 Sep 15 issue of the Journal. The Journal also invited Dr Lane to be the guest editor of the 2018 Sep 15 issue, with the theme of “Translating biology to treatment in schizophrenia”. Moreover, at 60th anniversary tea party of Ministry of Science and Technology, the article was recommended by the Department of Life Sciences as one of Taiwan's leading scientific research achievements in the world.
5. According to the information from World Health Organization, depression is one of three main diseases in the world that we need to concern highly. Our consortium continues to conduct clinical trials related to depression. For example, using low-dose ketamine and Transcranial Magnetic Stimulation (TMS) to treat depression. Our Co-PI, Dr. Cheng-Ta Li has obtained the 16th Tien Te Lee Biomedical Award, highlighting his distinguished contribution on treating the treatment-resistant depression using TMS. In addition, Co-PIs, Dr. Cheng-Ta Li and Ya-Mei Bai published a paper in Psychiatry Research (SCI Impact Factor: 11.225) in October 2022. The results from the trial suggested that depressed patients with acute suicidal ideation can improve their mood within one day after the treatment of low-dose ketamine, while patients could have better long-term antidepressant effect using TMS. This significant result has been reported by the media, and the finding was expected to have important beneficial effect for our society.

Milestone of our consortium:

1. In December, 2022, PI, Dr. Hsien-Yuan Lane and the Co-PI, Dr. Chieh-Hsin Lin obtained the 19th National Innovation Award, highlighting their distinguished contribution to the novel diagnosis of Alzheimer’s disease.

2. In October, 2022, Dr. Hsien-Yuan Lane and Dr. Chieh-Hsin Lin obtained the 2022 Future Tech Award, highlighting their distinguished contribution to the novel diagnosis of Alzheimer’s disease.

3. In October, 2022, Dr. Hsien-Yuan Lane and Dr. Chieh-Hsin Lin were shortlisted for the 2022 National Pharmaceutical Technology & Research Development Award, highlighting their distinguished contribution to novel therapy of dementia.

4. In September, 2022, Dr. Hsien-Yuan Lane obtained the Best Poster Award(first place) of the 16th International Congress of Asian Society Against Dementia, highlighting his distinguished contribution to the anti-dementia field.

5. In October, 2021, Dr. Hsien-Yuan Lane and the Co-PI, Dr. Ruu-Fen Tzang obtained the 18th National Innovation Award, highlighting their distinguished contribution in using sodium benzoate as a novel therapy for anti-NMDAR encephalitis.