Insulin Resistance in Patients With Mood Disorder
Condition: Depression; Bipolar Disorder; Insulin Resistance
MeSH terms: Insulin Resistance; Bipolar Disorder
Study type: Interventional

Summary: 
      Insulin resistance is known to be associated with mood disorders and cognitive difficulties.
      The purpose of this study is to treat depressed patients with rosiglitazone (also known as
      [AKA] Avandia), therefore improving glucose sensitivity, which in turn has the potential to
      affect mood and thinking. We, the researchers at Stanford University, are recruiting men and
      women who have been diagnosed with depression, and are willing to participate in this 3 month
      study. Participation involves neuropsychological testing, 2 blood draws called an oral
      glucose tolerance test (OGTT), which tests for glucose and insulin levels, and the
      medication, rosiglitazone. Participants are allowed to continue on their current psychiatric
      medication.
    

Detailed description: 
      An association between insulin resistance (IR) and affective disorders has been postulated in
      a number of cross-sectional studies. Limited data exist on potential changes in IR associated
      with improvement in depressive symptoms and/or depression remission resolution - two studies
      reported decreased IR after successful antidepressant treatment, while another study reported
      persisting IR even after successful treatment.

      We have postulated that IR is a part of the pathophysiology of affective disorders, and its
      improvement (via pharmacological or nonpharmacological treatments) may significantly reduce
      the severity of depressive symptoms. In support of this hypothesis, we previously reported
      increased IR in women with bipolar disorder, as well as a significant association between IR
      and depressive symptoms in women with primary IR syndrome (polycystic ovary syndrome [PCOS]).
      In the current pilot study, we attempted a more direct testing of the hypothesis that
      improvement of IR will result in improvement in mood in patients with depressive disorders.
      The aim of the study was to evaluate whether addition of the peroxisome
      proliferator-activated receptor-γ (PPAR) agonist rosiglitazone to the treatment as usual
      (TAU) of nondiabetic patients with unipolar or bipolar depression would result in improvement
      in depression severity and clinical global impression (CGI). Insulin sensitizing agents have
      proven efficacious in nondiabetic IR, or "prediabetic", individuals. All subjects in this
      pilot study had elevated fasting plasma glucose (FPG) and ratios of high density lipoproteins
      (HDL) to triglycerides (TG), which are established surrogate markers of IR.

      In the current pilot study, we attempted a more direct testing of the hypothesis that
      improvement of IR will result in improvement in mood in patients with depressive disorders.
      The aim of the study was to evaluate whether addition of the peroxisome
      proliferator-activated receptor-γ (PPAR) agonist rosiglitazone to the treatment as usual
      (TAU) of nondiabetic patients with unipolar or bipolar depression would result in improvement
      in depression severity and clinical global impression (CGI). Insulin sensitizing agents have
      proven efficacious in nondiabetic IR, or "prediabetic", individuals. All subjects in this
      pilot study had elevated fasting plasma glucose (FPG) and ratios of high density lipoproteins
      (HDL) to triglycerides (TG), which are established surrogate markers of IR.
    

Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention description(s): Rosiglitazone was administered at two different doses over the 12-week period.
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment