Phase 4
Completed N=37
Pioglitazone in Patients With Mood Disorders
Source: ClinicalTrials.gov NCT01559857 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Hamilton Depression Rating Scale at Baseline — 15.22; 13.67; 19.22; 13.25 units on a scale
◆ Published Evidence
Established
35citations · ~4 / year
Telomere length as a predictor of response to Pioglitazone in patients with unremitted depression: a preliminary study.
Summary
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.
Linked Publications
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Telomere length as a predictor of response to Pioglitazone in patients with unremitted depression: a preliminary study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale at Baseline |
15.22; 13.67; 19.22; 13.25 | — |
| SECONDARY Fasting Insulin Measurements at Baseline |
10.61; 9.18; 13.98; 14.12 | — |
| SECONDARY Change in HDRS-21: From Baseline to 12 Weeks |
-4.45; -3.57; -1.71; -3.57 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01559857) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.