Vortioxetine for Menopausal Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-12

Study Completion Date

2016-09-29

Brief Summary

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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.

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Detailed Description

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Forty-seven peri- and postmenopausal women were enrolled in this open-label study. This was an 8-week intervention using open-label vortioxetine with flexible dose between 5-20 mg, dependent on participant response and tolerability. In addition to assessment of depressive symptoms, improvement of menopause-related physical and emotional symptoms that occur with MDD, including vasomotor symptoms, cognition, fatigue, anxiety, sleep complaints, and quality of life, were also examined.

Conditions

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Depression Menopause Vasomotor Disturbance Hot Flashes Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open-label vortioxetine

flexible-dose vortioxetine of 5-20 mg depending on tolerability

Group Type EXPERIMENTAL

vortioxetine

Intervention Type DRUG

Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.

Interventions

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vortioxetine

Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.

Intervention Type DRUG

Other Intervention Names

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Trintellix

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

62 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No