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NCT01559857 · ClinicalTrials.gov registry record · Phase 4
Pioglitazone in Patients With Mood Disorders
A Phase 4 study of Major Depressive Disorder and Insulin Resistance, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01559857: Completed Phase 4 study of Major Depressive Disorder and Insulin Resistance, sponsored by Stanford University.
NCT01559857 is a Phase 4 study of Major Depressive Disorder and Insulin Resistance that has completed, run by Stanford University. The registered enrollment target is 37 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01559857, a Phase 4 study of Major Depressive Disorder and Insulin Resistance, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.
Conditions Studied
Interventions
- DRUG Pioglitazone
- DRUG Sugar Pill
Study Locations (1)
California
- Stanford University Department of Psychiatry & Behavioral Sciences - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01559857 record still lists
NCT01559857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Pioglitazone is the first listed.
NCT01559857 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01559857 about?
NCT01559857 is a clinical study titled "Pioglitazone in 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...
What is the current status of trial NCT01559857?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2011-11. Estimated completion is 2014-06.
What conditions does trial NCT01559857 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Insulin Resistance.
What interventions are being tested in trial NCT01559857?
The interventions under investigation include: Pioglitazone (DRUG), Sugar Pill (DRUG).
Who is sponsoring clinical trial NCT01559857?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01559857 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01559857's enrollment target sits among peer trials
37 211th of 282 higher than 71 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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