DepressionPhase 4NCT02234362
Vortioxetine for Menopausal Depression
A Phase 4 study testing vortioxetine in people with Depression and Menopause, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 62 years, women only
- Conditions the study is for
- Depression, Menopause, Vasomotor Disturbance
- What is being tested?
- vortioxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2015to 29 Sep 2016
- Phase
- Phase 4
- 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 40 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including:
- Perimenopausal women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician
- Women who are using the Mirena Intrauterine Device (IUD), with Follicle-stimulating hormone (FSH) level > 20 milli-International unit/ml (mIU/mL)
- 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.)
- MADRS scores of at least 20 at baseline visit
- Women with significant menopause-related physical symptoms, indicated by any of the following criteria:
Show all 10Show fewer
- Greene Climacteric Scale total scores > 20;
- Greene Climacteric Scale sub-score for vasomotor symptoms >3;
- 14 or more bothersome hot flashes per week (self-reported).
- Signed informed consent.
Who cannot join
- Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast feeding.
- 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.
- History of or current mania/hypomania, psychosis, or bipolar disorder
- Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit
- Serious suicidal ideation or intent
- Women who have used psychoactive or centrally acting medications within 2 weeks prior to study screening
Show all 29Show fewer
- Women who have received hormonal intervention within 1 month prior to study entry
- Known hypersensitivity to vortioxetine or any of the inactive ingredients
- 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
- Treatment with linezolid or intravenous methylene blue
- Patients with severe hepatic impairment
- Uncontrolled hypertension (>160/90 mmHg)
- Resting heart rate >110/minute
- Any current severe or unstable medical illness
- Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
- Drug or alcohol abuse in the past 1 year
- Use of any disallowed medications (specified in the Excluded Concomitant Medication section below)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Vortioxetine for Menopausal Depression and Associated Symptoms
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.
Read the detailed description
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
- Depression, Menopause, Vasomotor Disturbance, Hot Flashes, Sleep
- Being tested
- vortioxetine
- Medical subject headings
- Depression, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vortioxetineDrug
Also called Trintellix
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.
| Study group | Role | What they receive |
|---|---|---|
| open-label vortioxetine | Experimental | flexible-dose vortioxetine of 5-20 mg depending on tolerability Receives: Drug: vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.
Measured: Baseline and Week 8 (Visit 5)
Secondary outcomes (13)
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Severity of VMS:
The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.
Severity of VMS:
The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)
Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)
Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)
Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)
Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).
The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2", plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)
Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)
Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)
Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)
Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:
- Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).
A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63.
Measured: Baseline and Week 8 (Visit 5)
Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)
Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).
The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63.
Measured: Baseline and Week 8 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start12 Jun 2015
- Primary completion29 Sep 2016
- Study completion29 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Marlene P. Freeman, MD, Massachusetts General Hospital
- Investigators
- Marlene P Freeman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234362
- Sponsor's protocol ID
- 2014P001812
- Status last verified
- Jun 2017
- First submitted
- 5 Sep 2014
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bang-Andersen B, Ruhland T, Jorgensen M, Smith G, Frederiksen K, Jensen KG, Zhong H, Nielsen SM, Hogg S, Mork A, Stensbol TB. Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011 May 12;54(9):3206-21. doi: 10.1021/jm101459g. Epub 2011 Apr 12.
PubMed 21486038Bromberger JT, Assmann SF, Avis NE, Schocken M, Kravitz HM, Cordal A. Persistent mood symptoms in a multiethnic community cohort of pre- and perimenopausal women. Am J Epidemiol. 2003 Aug 15;158(4):347-56. doi: 10.1093/aje/kwg155.
PubMed 12915500Loprinzi CL, Kugler JW, Sloan JA, Mailliard JA, LaVasseur BI, Barton DL, Novotny PJ, Dakhil SR, Rodger K, Rummans TA, Christensen BJ. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. Lancet. 2000 Dec 16;356(9247):2059-63. doi: 10.1016/S0140-6736(00)03403-6.
PubMed 11145492Pehrson AL, Cremers T, Betry C, van der Hart MG, Jorgensen L, Madsen M, Haddjeri N, Ebert B, Sanchez C. Lu AA21004, a novel multimodal antidepressant, produces regionally selective increases of multiple neurotransmitters--a rat microdialysis and electrophysiology study. Eur Neuropsychopharmacol. 2013 Feb;23(2):133-45. doi: 10.1016/j.euroneuro.2012.04.006. Epub 2012 May 20.
PubMed 22612991Pehrson AL, Sanchez C. Serotonergic modulation of glutamate neurotransmission as a strategy for treating depression and cognitive dysfunction. CNS Spectr. 2014 Apr;19(2):121-33. doi: 10.1017/S1092852913000540. Epub 2013 Aug 1.
PubMed 23903233
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine for Menopausal Depression and Associated Symptoms
- ClinicalTrials.gov ID
- NCT02234362
- Acronym / sponsor ID
- 2014P001812
- Conditions
- Depression, Menopause, Vasomotor Disturbance, Hot Flashes, Sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label vortioxetine | Experimental | Drug: vortioxetineflexible-dose vortioxetine of 5-20 mg depending on tolerability |
Who may qualify
- Ages
- 40 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including:
- 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.)
- MADRS scores of at least 20 at baseline visit
- Women with significant menopause-related physical symptoms, indicated by any of the following criteria:
- Signed informed consent.
Key exclusion criteria (29 listed)
- Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast feeding.
- 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.
- History of or current mania/hypomania, psychosis, or bipolar disorder
- Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit
- Serious suicidal ideation or intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vortioxetineAlso: TrintellixEligible 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. | Drug | open-label vortioxetine |
Primary outcome
Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.
13 secondary outcomes
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)
Time frame: Baseline and Week 8 (Visit 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21486038Bang-Andersen B, Ruhland T, Jorgensen M, Smith G, Frederiksen K, Jensen KG, Zhong H, Nielsen SM, Hogg S, Mork A, Stensbol TB. Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder. J Med Chem. 2011 May 12;54(9):3206-21. doi: 10.1021/jm101459g. Epub 2011 Apr 12.
- Background: PubMed 12915500Bromberger JT, Assmann SF, Avis NE, Schocken M, Kravitz HM, Cordal A. Persistent mood symptoms in a multiethnic community cohort of pre- and perimenopausal women. Am J Epidemiol. 2003 Aug 15;158(4):347-56. doi: 10.1093/aje/kwg155.
- Background: PubMed 11145492Loprinzi CL, Kugler JW, Sloan JA, Mailliard JA, LaVasseur BI, Barton DL, Novotny PJ, Dakhil SR, Rodger K, Rummans TA, Christensen BJ. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. Lancet. 2000 Dec 16;356(9247):2059-63. doi: 10.1016/S0140-6736(00)03403-6.
- Background: PubMed 22612991Pehrson AL, Cremers T, Betry C, van der Hart MG, Jorgensen L, Madsen M, Haddjeri N, Ebert B, Sanchez C. Lu AA21004, a novel multimodal antidepressant, produces regionally selective increases of multiple neurotransmitters--a rat microdialysis and electrophysiology study. Eur Neuropsychopharmacol. 2013 Feb;23(2):133-45. doi: 10.1016/j.euroneuro.2012.04.006. Epub 2012 May 20.
- Background: PubMed 23903233Pehrson AL, Sanchez C. Serotonergic modulation of glutamate neurotransmission as a strategy for treating depression and cognitive dysfunction. CNS Spectr. 2014 Apr;19(2):121-33. doi: 10.1017/S1092852913000540. Epub 2013 Aug 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene P Freeman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vortioxetine in people with Depression and Menopause, run by Massachusetts General Hospital at 1 site in United States.
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 10 inclusion and 29 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 May 2017). 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 Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5) (time frame: Baseline and Week 8 (Visit 5)). 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 NCT02234362, which also lists 5 linked publications.
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 28 Jun 2017.