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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental | Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score | Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome | Week 0 - Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score | The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome | Week 0 - Week 8 |
| Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Kemp, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24715548 | Derived | Kemp DE, Schinagle M, Gao K, Conroy C, Ganocy SJ, Ismail-Beigi F, Calabrese JR. PPAR-gamma agonism as a modulator of mood: proof-of-concept for pioglitazone in bipolar depression. CNS Drugs. 2014 Jun;28(6):571-81. doi: 10.1007/s40263-014-0158-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score | Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0 - Week 8 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carla Conroy | University Hospitals Case Medical Center | 216-844-2871 | carla.conroy@Uhhospitals.org |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D001714 | Bipolar Disorder |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit. |
| Week 0 - Week 8 |
| Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores | A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8. | Week 0 - Week 8 |
| Change in Clinical Global Impressions-Bipolar Version (CGI-BP) | The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. | Week 0 - Week 8 |
| Withdrawal by Subject |
|
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Bipolar Subtype | Number | participants |
|
| Age of depression onset | Mean | Standard Deviation | years |
|
| Age of mania/hypomania onset | Mean | Standard Deviation | years |
|
| Age first treated for depression | Mean | Standard Deviation | years |
|
| Age first treated for mania/hypomania | Mean | Standard Deviation | years |
|
| Duration of mood state | Mean | Standard Deviation | days |
|
| Number of prior hospitalizations | Mean | Standard Deviation | hospitalizations |
|
| Number of prior suicide attempts | Mean | Standard Deviation | suicide attempts |
|
| Employed | Number | participants |
|
| Medication treatment failures during current episode | Number | participants |
|
| Comorbid diagnoses | Number | participants |
|
| History of physical abuse | Number | participants |
|
| History of verbal abuse | Number | participants |
|
| History of sexual abuse | Number | participants |
|
| Metabolic syndrome | Number | participants |
|
| Insulin resistance | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score | The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0 - Week 8 |
|
|
|
| Secondary | Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) | A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit. | Posted | Number | participants | Week 0 - Week 8 |
|
|
|
| Secondary | Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores | A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8. | Posted | Number | participants | Week 0 - Week 8 |
|
|
|
| Secondary | Change in Clinical Global Impressions-Bipolar Version (CGI-BP) | The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 0 - Week 8 |
|
|
|
| 0 |
| 34 |
| 16 |
| 34 |
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Increased Appetite | General disorders | Non-systematic Assessment |
|
| Peripheral Edema | General disorders | Non-systematic Assessment |
|
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| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |