Pioglitazone for the Treatment of Bipolar Depression

NCT01717040 | Terminated Phase 4 Results DMC

• 1 other identifier: Kemp DBDAT
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to test the hypothesis that adjunctive pioglitazone is more effective than placebo for the relief of acute depressive symptoms resulting from bipolar disorder. The secondary objectives are to determine potential moderators and mediators of antidepressant efficacy.

Conditions

Bipolar Disorder; Insulin Resistance

Keywords

Bipolar Disorder; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

  Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms

  Baseline and Week 8

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pioglitazone DRUG

Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.

Also known as: Actos

Pioglitazone

Placebo DRUG

Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Be male or female \>= 18 years of age
• Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder (type I, II, or NOS)
• Currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.)-Plus at the screening visit
• Inventory of Depressive Symptoms total score \> 25 or Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) \> 11 at study baseline
• Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.

You may not qualify if:

• Pregnant or breast feeding
• Unstable or inadequately treated medical illness as judged by the investigator
• Severe personality disorder
• Serious suicidal risk as judged by the investigator or having a score ≥ 4 on Montgomery Asberg Depression Rating Scale (MADRS) item number 10 (suicidal thoughts) at screening or baseline
• Known history of intolerance or hypersensitivity to pioglitazone
• Treatment with pioglitazone in the 3 months prior to randomization
• Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry
• Currently taking insulin or rosiglitazone.
• Diagnosed with dementia
• Acute Mania as defined by a Young Mania Rating Scale (YMRS) score \> 15
• Diagnosed with heart failure
• Transaminase elevation \>2.5 times the upper limit of normal
• Presence of renal impairment (eg. creatinine \> 1.5)
• History of bladder carcinoma
• Fasting blood glucose \>150 mg/dL and Hb A1c\> 7%; participants meeting these criteria will be referred to an endocrinologist or their primary care physician for a diabetes evaluation and education.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Aftab A, Kemp DE, Ganocy SJ, Schinagle M, Conroy C, Brownrigg B, D'Arcangelo N, Goto T, Woods N, Serrano MB, Han H, Calabrese JR, Gao K. Double-blind, placebo-controlled trial of pioglitazone for bipolar depression. J Affect Disord. 2019 Feb 15;245:957-964. doi: 10.1016/j.jad.2018.11.090. Epub 2018 Nov 13.

  PMID: 30699881 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Insulin Resistance

Interventions

Pioglitazone; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Carla Conroy, MPH
• Organization: Univeristy Hospitals Cleveland Medical Center

carla.conroy@UHhospitals.org

216-844-2871

Study Officials

• David Kemp, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Director, Mood Disorders Program

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: October 30, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)