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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH09931501A1 | Other Identifier | National Institute of Mental Health |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Lawley Pharmaceuticals | INDUSTRY |
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The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive symptoms in women with Major Depressive Disorder (MDD) and antidepressant partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation improves fatigue and sexual dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Active Comparator | Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels. |
|
| Placebo | Placebo Comparator | Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptom Severity | Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale. | Week 8 |
| Sexual Dysfunction | Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Miller, MD | Massachusetts General Hospital | Principal Investigator |
| Maurizio Fava, MD | Massachusetts General Hospital | Principal Investigator |
| Linda L Carpenter, MD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Butler Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660299 | Derived | Dichtel LE, Carpenter LL, Nyer M, Mischoulon D, Kimball A, Deckersbach T, Dougherty DD, Schoenfeld DA, Fisher L, Cusin C, Dording C, Trinh NH, Pedrelli P, Yeung A, Farabaugh A, Papakostas GI, Chang T, Shapero BG, Chen J, Cassano P, Hahn EM, Rao EM, Brady RO Jr, Singh RJ, Tyrka AR, Price LH, Fava M, Miller KK. Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study. Am J Psychiatry. 2020 Oct 1;177(10):965-973. doi: 10.1176/appi.ajp.2020.19080844. Epub 2020 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone | Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels. Testosterone |
| FG001 | Placebo | Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone | Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels. Testosterone |
| BG001 | Placebo | Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. Placebo |
| 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 | Depressive Symptom Severity | Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale. | Posted | Mean | Standard Error | units on a scale | Week 8 |
|
8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
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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 | Testosterone | Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels. Testosterone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen K. Miller | Massachusetts General Hospital | 617-726-3870 | KKMILLER@MGH.HARVARD.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | May 3, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2017 | May 3, 2018 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| Week 8 |
| Providence |
| Rhode Island |
| 02906 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Mean MADRS Score | Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale. | Mean | Standard Deviation | units on a scale |
|
| Postmenopausal | Count of Participants | Participants |
|
| Brief Fatigue Inventory | Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale. | Mean | Standard Deviation | units on a scale |
|
| Derogatis Inventory of Sexual Function | Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Fatigue | Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale. | Posted | Mean | Standard Error | units on a scale | Week 8 |
|
|
|
| Secondary | Sexual Dysfunction | Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160. | Posted | Mean | Standard Error | units on a scale | Week 8 |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 15 |
| 51 |
| EG001 | Placebo | Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. Placebo | 0 | 50 | 0 | 50 | 13 | 50 |
| Hot flashes | Reproductive system and breast disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |