Programs of Research Report
Joseph R Calabrese, MD; Trisha Suppes, MD, Ph.D., et al. “A Double Bind, Placebo-Controlled, Prophylaxis Study of Lamotrigine in Rapid Cycling Bipolar Disorder .” J Clin. Psychiatry , 2000, www.psychiatrist.com/wp-content/uploads/2021/02/12717_double-blind-placebo-controlled-prophylaxis-study.pdf.
The main author is Trisha Suppes. Her website is embedded within Stanford University's website. Trisha has her M.D. and her Ph.D. I'm not entirely sure what stage her career seems to be at, but it seems like she has been doing research, and has been in the medical field for a long time. In 1996-2010 her peers elected her best doctor in America, she received a few other rewards and honors, and she has also published a lot of research articles. The main goal of her research is to further study the biology and treatments for bipolar disorder and other mood disorders. She currently studies the long-term treatments for bipolar disorder, identification of bipolar disorder, and co-morbidities with bipolar disorder.
This trial was double-blind and was done on humans. The patients who were eligible to participate in these trials were men and women who were older than 18 and were diagnosed with bipolar 1 or bipolar 2 as per the DSM-5. Patients required to be in good physical health had to go for labs, ECGs, physical exams, etc. Patients who were not allowed to participate in this experiment were patients who had a panic disorder, were suicidal, had OCD, social phobia, or had an eating disorder within the last year. As stated before, the study was ‘double-blind, flexible-dose, placebo-controlled, parallel-group designed’. The study was run in a preliminary phase, which is the first phase, and then in a randomized phase, which is the second phase. During the preliminary phase, the patients were typically brought in with euthymia or mood episodes such as mania, hypomania, depression, etc. The patients were started on lamotrigine with a target dosage of 200mg/day; which means in the first two weeks they were given 25mg per day, in the third and fourth weeks they were given 50mg per day, and in the fifth week they were given 100mg per day. After the fifth week concluded the doses of lamotrigine were adjusted if they needed to be, but the range was from 100mg to 300mg per day. Patients were taken to clinics for screening visits (Mania Rating Scale, medical and psychiatric history, etc). These screening visits were conducted on the first day of the preliminary phase, 14 days after the preliminary phase, and the visits were randomized weekly. If a patient was experiencing mood episodes, other psychotropic medications were allowed to be used, but only during the first 4 weeks. After 4 to 8 weeks of exposure to lamotrigine, the other psychotropic medications were reduced or diminished because the patient was considered to have met the criteria for wellness; this criterion was that the patients were given a daily minimum dose of 100mg of lamotrigine with low scores on the tests from the screening visits. During the randomized phase, the patients were assigned a 1:1 ratio treatment with lamotrigine and a placebo in a double-blind fashion. The lamotrigine and the placebo were given in 100mg tablets and were administered once a day. If patients began to experience a change in symptoms, the dosage of the lamotrigine and the placebo (double-blind) were increased to the next dose, but the maximum dosage was 500mg.
Mauricio Tohen, MD, DrPH; Trisha Suppes, MD, Ph.D.; et al. “Efficacy of Olanzapine in Combination with Valproate or Lithium in the Treatment of Mania in Patients Partially Nonresponsive to Valproate or Lithium Monotherapy.” Archives of General Psychiatry, U.S. National Library of Medicine, 2002, pubmed.ncbi.nlm.nih.gov/11779284/.
This study looked at how effective olanzapine was in combination with lithium or valproate. All patients in this study had to be diagnosed with bipolar disorder and have manic or mixed episodes. During study period one, the patients were entered into a 2-7 day “screening and washout period” in which all medications other than lithium and valproate were discontinued. Patients who were taking other types of medication were started on either lithium or valproate. Patients were assessed by being given the YMRS (young mania rating scale), and only the patients who scored greater than or equal to 16 were given the randomized treatment of either olanzapine or a placebo. During study period two, there was a 6-week double-blind phase where levels of lithium and valproate were still being given. Patients were then given a randomized 2:1 ratio to add olanzapine to valproate or lithium or a placebo to valproate or lithium.
McElroy, Susan L., Suppes, Trisha,. et al. “Axis I Psychiatric Comorbidity and Its Relationship to Historical Illness Variables in 288 Patients with Bipolar Disorder.” American Journal of Psychiatry, 1 Mar. 2001, ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.158.3.420.
Axis I disorders are disorders like schizophrenia, anxiety, eating, and sleep disorders. It is believed that axis I disorders exist along with bipolar disorder. The methods section in this article takes 288 bipolar disorder patients and gives them "self-rated" questionnaires to diagnose them with axis I co-morbid disorders.