Pioglitazone in Patients With Mood Disorders
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Psychiatric, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | November 2011 |
| End Date: | June 2014 |
| Contact: | Rachael Lazar |
| Email: | rlazar@stanford.edu |
| Phone: | 650-724-4559 |
Pioglitazone Treatment for Insulin Resistant Patients With Mood Disorders
The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can
cause changes in mood in some depressed patients. Study participants receive assessment of
their cognitive and metabolic functioning.
If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a
90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting
insulin and glucose levels, as well as routine blood testing.
The investigators hope to quantify the role of Pioglitazone in patients with mood disorders
and compare the values to those previously obtained in a healthy age-matched control
population. The investigators also hope to examine the association between IR and cognitive
performance and clinical course of depression in patients with mood disorders.
cause changes in mood in some depressed patients. Study participants receive assessment of
their cognitive and metabolic functioning.
If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a
90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting
insulin and glucose levels, as well as routine blood testing.
The investigators hope to quantify the role of Pioglitazone in patients with mood disorders
and compare the values to those previously obtained in a healthy age-matched control
population. The investigators also hope to examine the association between IR and cognitive
performance and clinical course of depression in patients with mood disorders.
Inclusion Criteria:
- Age between 20 and 65 years
- BMI between 25 and 35
- Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD)
or depressive episode of bipolar disorder (Bipolar I, II or NOS)
- Depression severity as defined by score of < 12 on the 21-item Hamilton Rating Scale
for Depression and no psychiatric admission within 6 months from study entry and no
suicide attempt within the last 12 months
- Willingness to sign human subjects consent form
Exclusion Criteria:
- Diagnosis of possible or probable cognitive impairment
- For women only: pregnancy, breastfeeding
- Personal history of Type I or Type II diabetes
- Unstable cardiovascular disease or other major medical condition, or history of
myocardial infarction within the previous year
- Significant cerebrovascular disease, as evidenced by neurological examination,
uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures
> 100)
- Current drug or alcohol abuse
- History of neurological disorder, e.g. multiple sclerosis, stroke etc
- Use of any drug that may significantly affect psychometric testing or the insulin
testing
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