Medical Student Research Fellowship for Summer 2007

Mentor: Trisha Suppes M.D., Ph.D.
Department: Psychiatry
Room number: FL7.722
Mail Code: 9121
Phone number: 214-648-6925
E-mail: trisha.suppes@utsouthwestern.edu
Four Projects

Project I title: A Double-blind, Placebo-Controlled Trial of Seroquel for the treatment of Dysphoric Hypomania in Bipolar II Patients
Human subjects IRB approved project number (where applicable): 1103-715
Animal subjects IRB approved project number (where applicable):
Project Type patient-based research
Brief Description of Project:
Bipolar II (BDII) patients make up a substantial percentage of patients with bipolar disorder, estimated conservatively at 0.5% of the US population and, with somewhat more liberal definitions of hypomania minimum duration, in Europe at 1% or greater. Importantly, few to virtually no recent treatment trials of high quality have been undertaken in BDII. The initial trials for the registration of quetiapine for bipolar disorder did not include patients with mixed symptoms. The trial proposed will provide data useful to the clinician in a real world setting, as well as provide data in an area not previously covered by the trial registration studies. The specific aim of this protocol is to evaluate the efficacy of quetiapine as add-on therapy versus placebo to stable medication regimens or used as monotherapy for the treatment of patients with bipolar II disorder experiencing hypomania and depressive symptoms ("dysphoric hypomania").

The study is a randomized, placebo-controlled, double-blind, 8-week investigation of quetiapine for the treatment of patients diagnosed with bipolar II disorder who are experiencing dysphoric hypomania. The primary outcome is improvement on the Global Impression Scale (CGI-BP), with other mood measures providing secondary outcome assessments. The goals for the medical student would be to observe clinicians, both physicians and research staff, during intake and evaluation visits to gain practical knowledge of research in patients with bipolar disorder. The medical student will learn how to rate patients with bipolar disorder with several commonly used mood rating scales. The student will learn how to collect data and verify diagnoses for research purposes, as well as receive an introduction to basic research data management and outcome analyses. The student will assist in preparing pilot data for a poster presentation.

Project II title: A Randomized, Double-Blind, Placebo-Controlled Study of Quetiapine SR Monotherapy and Divalproex Sodium ER Monotherapy, in Ambulatory Bipolar Disorder with Current at Least Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder
Human subjects IRB approved project number (where applicable): submitted but pending
Animal subjects IRB approved project number (where applicable):
Project Type: patient-based research
Brief Description of Project:
Bipolar disorder often co-occurs with anxiety disorders at a rate of up to 40%. Research shows that bipolar disorder associated with anxiety is also a clinically relevant subtype of bipolar disorder. Bipolar patients with anxiety tend to have an earlier age of illness onset, higher rates of mixed states, depressive symptoms and suicidality, and poor response to lithium based treatment. Therefore, there is a need for an alternate mood-stabilizing agent that helps patients with this subtype of bipolar disorder and/or one that possesses anti-anxiety properties. The purpose of this study is to evaluate the safety, tolerability and efficacy of quetiapine SR monotherapy and divalproex ER monotherapy versus placebo monotherapy in the treatment of bipolar disorder with comorbid panic disorder or generalized anxiety disorder.
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy and divalproex sodium ER (extended release) monotherapy compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. The primary outcome measure is the Clinician Global Improvement Scale for Anxiety Symptoms (CGI-21), with several other anxiety and mood measures providing secondary outcome assessments. The goals for the medical student would be to observe clinicians, both physicians and research staff, during intake and evaluation visits to gain practical knowledge of research in patients with bipolar disorder. The medical student will learn how to rate patients with bipolar disorder with several commonly used mood rating scales. Medical students will also gain practical knowledge of differential diagnosis, as symptoms of bipolar disorder and anxiety often overlap, making diagnosis of the underlying disorder difficult. The student will learn how to collect data and verify diagnoses for research purposes, as well as receive an introduction to basic research data management and outcome analyses.

Project III title: A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder with Current Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder
Human subjects IRB approved project number (where applicable): 042004-002
Animal subjects IRB approved project number (where applicable):
Project Type: patient-based research
Brief Description of Project:
Bipolar disorder often co-occurs with anxiety disorders (up to 40% of patients). Research shows that bipolar disorder associated with anxiety is also a clinically relevant subtype of bipolar disorder. Bipolar patients with anxiety tend to have an earlier age of illness onset, higher rates of mixed states, depressive symptoms and suicidality, and poor response to lithium based treatment. Therefore, there is a need for an alternate mood-stabilizing agent that helps patients with this subtype of bipolar disorder and/or one that possesses anti-anxiety properties. The purpose of this study is to evaluate the safety, tolerability and efficacy of risperidone in the treatment of bipolar disorder with comorbid panic disorder or generalized anxiety disorder.
This is a randomized double-blind placebo controlled, parallel-group trial of risperidone monotherapy compared to placebo in subjects with lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current at least moderately severe anxiety symptoms. The primary outcome measure will be improvement as measured by the CGI-21. Additional mood and safety assessments are completed for secondary analyses. The goals for the medical student will be to review the data in the database. The student will learn how to "clean" and manage data, gain first hand experience with data analysis, and learn how to present research data. Students are encouraged to choose a specific area of interest from the research database and, with the supervision and guidance of Dr. Suppes, develop a poster.

Previous Research Activities or Publications with Medical Students:
Dr. Suppes has mentored several medical students and graduate psychology students. Previous medical students who have been significantly involved with research have been included in publications such as Suppes T, Kelly DI, Hynan LS, Snow D, Foster B, Curley E. A comparison of two anticonvulsants in a randomized, single-blind treatment of hypomanic symptoms in patients with bipolar disorder. Australian and New Zealand Journal of Psychiatry 2007, in press.

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