Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

NCT01364649 | Completed Phase 3 Results

• 2 other identifiers: LuAA21004_318U1111-1120-3483
• Study Type: interventional
• Target: 447
• Locations: 2 countries
• Sites: 62

Brief Summary

The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

Conditions

Treatment Outcome

Keywords

Sexual Dysfunction, Physiological; Depressive Disorder, Major; Depression; Antidepressive Agents; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8

  The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.

  Baseline, Week 8

Secondary Outcomes (2)

• Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed

  Baseline and Weeks 1, 2, 4 and 6

• Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed

  Baseline and Weeks 1, 2, 4, 6 and 8

Study Arms (2)

Vortioxetine

EXPERIMENTAL

Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg, tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.

Drug: Vortioxetine; Drug: Placebo

Escitalopram

ACTIVE COMPARATOR

Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only.

Drug: Escitalopram

Interventions

Vortioxetine DRUG

Vortioxetine tablets

Also known as: Lu AA21004

Vortioxetine

Escitalopram DRUG

Escitalopram tablets

Also known as: Lexapro

Escitalopram

Placebo DRUG

Vortioxetine Placebo-matching capsules

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is a man or a woman aged between 18 and 55 years, inclusive, who is currently being treated with selective serotonin reuptake inhibitor (SSRI) monotherapy (only citalopram, paroxetine, or sertraline allowed) for at least 8 weeks, which was prescribed to treat a major depressive episode (MDE), according to the DSM-IV-TR criteria.
• Is currently stable; and has a Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score of ≤3.
• Is currently experiencing treatment-emergent sexual dysfunction (TESD; defined as a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score ≤41 for women and ≤47 for men), considered to be attributable to the current SSRI monotherapy and is suitable for a switch.

You may not qualify if:

• Has previously participated in a Lu AA21004 clinical study.
• Has 1 or more the following: any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; as assessed by the Mini International Neuropsychiatric Interview Version 6.0.0); current or history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR; current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening (subject must also have negative urine drug screen prior to Baseline); presence or history of a clinically significant neurological disorder (including epilepsy); neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc); or any Axis II disorder that might compromise the study.
• Has sexual dysfunction associated with an etiology other than SSRI treatment or current MDE (e.g., due to a medical condition, such as diabetes or hypertension, a medication, a genital anatomical deformity, or alcohol abuse).
• Is nonsexually active or anticipates decreasing frequency of sexual activity (ie, sexual activity anticipated to lead to orgasm or that would normally lead to orgasm, which can include sexual intercourse, oral sex, masturbation, sexual fantasies, and/or thinking of sexual activity) during the course of the study below the level at study initiation.
• Is a male with a history of premature ejaculation in the past year.
• Has had major relationship changes during the preceding SSRI treatment period or plans to have major relationship changes during the course of the study.
• Has a sexual partner(s) who plans to initiate treatment for sexual dysfunction during the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (62)

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Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Chino, California, United States

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Costa Mesa, California, United States

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Encino, California, United States

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Escondido, California, United States

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Irvine, California, United States

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Newport Beach, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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Norwich, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Coral Springs, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lauderhill, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Sanford, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Gaithersburg, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Weymouth, Massachusetts, United States

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Flowood, Mississippi, United States

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Creve Coeur, Missouri, United States

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St Louis, Missouri, United States

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Toms River, New Jersey, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Waukesha, Wisconsin, United States

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Medicine Hat, Alberta, Canada

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Kelowna, British Columbia, Canada

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Penticton, British Columbia, Canada

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Sydney, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Chatham, Ontario, Canada

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Kingston, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Related Publications (1)

• Jacobsen PL, Nomikos GG, Zhong W, Cutler AJ, Affinito J, Clayton A. Clinical implications of directly switching antidepressants in well-treated depressed patients with treatment-emergent sexual dysfunction: a comparison between vortioxetine and escitalopram. CNS Spectr. 2020 Feb;25(1):50-63. doi: 10.1017/S1092852919000750.

  PMID: 31010445 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Depressive Disorder, Major; Depression

Interventions

Vortioxetine; Escitalopram

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Senior Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 9, 2014
• Results First Posted: October 9, 2014

Record last verified: 2014-10

Locations

US (53); CA (9)