Vortioxetine for Menopausal Depression

• Status: Completed
• Trial end date: 2016-09-29
• Target enrollment: 0
• Participant gender: Female

Summary

The broad goal of this study was to examine the efficacy and tolerability of vortioxetine (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women around the menopausal transition. We hypothesized that an eight-week treatment with vortioxetine would promote a significant improvement of depression symptoms and other menopause-related physical symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including:

1. Perimenopausal women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician

2. Women who are using the Mirena Intrauterine Device (IUD), with Follicle-stimulating hormone (FSH) level > 20 milli-International unit/ml (mIU/mL)

2. Women meeting Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depression (assessed by the Mini International Neuropsychiatric Interview - M.I.N.I.)

3. MADRS scores of at least 20 at baseline visit

4. Women with significant menopause-related physical symptoms, indicated by any of the following criteria:

1. Greene Climacteric Scale total scores > 20;

2. Greene Climacteric Scale sub-score for vasomotor symptoms >3;

3. 14 or more bothersome hot flashes per week (self-reported).

5. Signed informed consent.

Exclusion Criteria:

1. Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast feeding.

2. Women whose primary diagnosis is Panic Disorder, Obsessive Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), Seasonal Affective Disorder (SAD), or any other Axis I pathology active within 6 months prior to screening visit (except for specific phobias). Anxiety disorders are allowable if secondary to MDD as the primary diagnosis.

3. History of or current mania/hypomania, psychosis, or bipolar disorder

4. Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit

5. Serious suicidal ideation or intent

6. Women who have used psychoactive or centrally acting medications within 2 weeks prior to study screening

7. Women who have received hormonal intervention within 1 month prior to study entry

8. Known hypersensitivity to vortioxetine or any of the inactive ingredients

9. Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 21 days of discontinuation of study drug

10. Treatment with linezolid or intravenous methylene blue

11. Patients with severe hepatic impairment

12. Uncontrolled hypertension (>160/90 mmHg)

13. Resting heart rate >110/minute

14. Any current severe or unstable medical illness

15. Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period

16. Drug or alcohol abuse in the past 1 year

17. Use of any disallowed medications (specified in the Excluded Concomitant Medication section below)

18. Concurrent enrollment in another clinical trial

Excluded Concomitant Medications:

• Selective estrogen-receptor modulators (SERMs)

• Hormone replacement therapy

• Hormonal contraceptives, excluding Mirena IUD

• Natural menopause supplements

• Episodic sleep medications (chronic, regular, stable-dose benzodiazepines are allowed)

• Antidepressants

• Phytoestrogens

• Soy-based medications

• Steroids

• Anorectics, appetite depressants