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Treatment OutcomePhase 3NCT01364649

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

A Phase 3 study testing Vortioxetine and Escitalopram in people with Treatment Outcome, run by Takeda at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Treatment Outcome
What is being tested?
Vortioxetine and Escitalopram
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
447 participants
Where
62 sitesin 2 countries
Study dates
Jun 2011to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States53 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Coral Springs, Florida

  • Study site

    Costa Mesa, California

  • Study site

    Creve Coeur, Missouri

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Encino, California

  • Study site

    Escondido, California

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Myers, Florida

  • Study site

    Gainesville, Florida

  • Study site

    Gaithersburg, Maryland

  • Study site

    Irvine, California

  • Study site

    Jacksonville, Florida

  • Study site

    Joliet, Illinois

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lauderhill, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    New York, New York

  • Study site

    Newport Beach, California

  • Study site

    North Miami, Florida

  • Study site

    Norwich, Connecticut

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Rochester, New York

  • Study site

    San Diego, California

  • Study site

    Sanford, Florida

  • Study site

    Seattle, Washington

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    Staten Island, New York

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Towson, Maryland

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Waukesha, Wisconsin

  • Study site

    West Palm Beach, Florida

  • Study site

    Weymouth, Massachusetts

  • Study site

    Willingboro, New Jersey

Other trials in United States

Canada9 sites

  • Study site

    Burlington, Ontario

  • Study site

    Chatham, Ontario

  • Study site

    Kelowna, British Columbia

  • Study site

    Kingston, Ontario

  • Study site

    Medicine Hat, Alberta

  • Study site

    Mississauga, Ontario

  • Study site

    Penticton, British Columbia

  • Study site

    Sydney, Nova Scotia

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction

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

Read the detailed description

The drug being tested in this study is called Lu AA21004. Lu AA21004 is being tested to treat people who have major depressive disorder (MDD). This study will look at sexual function in people who take Lu AA21004.

The study will enroll approximately 440 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Lu AA21004 10 to 20 mg
  • Escitalopram 10 to 20 mg - This is a comparator drug that is also used to treat MDD.

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to answer questionnaires at each study visit.

This multi-centre trial will be conducted in the United States and Canada. The overall time to participate in this study is 14 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 21 days after last dose of study drug for a follow-up assessment.

Being tested
Vortioxetine, Escitalopram, Placebo
Keywords
Sexual Dysfunction, Physiological, Depressive Disorder, Major, Depression, Antidepressive Agents, Drug Therapy
Medical subject headings
Sexual Dysfunction, Physiological, Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VortioxetineDrug

    Also called Lu AA21004

    Vortioxetine tablets

  • EscitalopramDrug

    Also called Lexapro

    Escitalopram tablets

  • PlaceboDrug

    Vortioxetine Placebo-matching capsules

Study groups in NCT01364649
Study groupRoleWhat they receive
VortioxetineExperimentalVortioxetine 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.
Receives: Drug: Vortioxetine; Drug: Placebo
EscitalopramActive comparatorEscitalopram 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.
Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 8

Secondary outcomes (2)

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

    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.

    Measured: Baseline and Weeks 1, 2, 4 and 6

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

    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. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01364649
Sponsor's protocol ID
LuAA21004_318
Other IDs
U1111-1120-3483
Status last verified
Oct 2014
First submitted
31 May 2011
Last updated
9 Oct 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 31010445

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine and Escitalopram in people with Treatment Outcome, run by Takeda at 62 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01364649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.

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