Pioglitazone in Patients With Mood Disorders

NCT01559857 | Completed Phase 4 Results

• 1 other identifier: R21MH093948-01A1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Insulin Resistance

Keywords

Depression; Insulin resistance; Mood disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale at Baseline

  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.

  Baseline

Secondary Outcomes (2)

• Fasting Insulin Measurements at Baseline

  Baseline

• Change in HDRS-21: From Baseline to 12 Weeks

  12 weeks

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.

Drug: Pioglitazone

Sugar pill

PLACEBO COMPARATOR

50% of participants will be randomized to 12 weeks of treatment with placebo pill.

Drug: Sugar Pill

Interventions

Pioglitazone DRUG

30mg once daily for 12 weeks

Also known as: Actos

Pioglitazone

Sugar Pill DRUG

Placebo

Also known as: Placebo

Sugar pill

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University Department of Psychiatry & Behavioral Sciences

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Rasgon N, Lin KW, Lin J, Epel E, Blackburn E. Telomere length as a predictor of response to Pioglitazone in patients with unremitted depression: a preliminary study. Transl Psychiatry. 2016 Jan 5;6(1):e709. doi: 10.1038/tp.2015.187.

  PMID: 26731446 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Insulin Resistance; Depression; Mood Disorders

Interventions

Pioglitazone; Sugars

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Natalie Rasgon
• Organization: Stanford University

natalie.rasgon@stanford.edu

6507249694

Study Officials

• Natalie Rasgon, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 21, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)