Trial Outcomes & Findings for Vortioxetine for Menopausal Depression (NCT NCT02234362)
NCT ID: NCT02234362
Last Updated: 2017-06-28
Results Overview
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.
COMPLETED
PHASE4
47 participants
Baseline and Week 8 (Visit 5)
2017-06-28
Participant Flow
Participants were recruited through advertisements in the greater Boston metropolitan area.
Participant milestones
| Measure |
Open-label Vortioxetine
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
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|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
Received at Least One Dose of Medication
|
27
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Open-label Vortioxetine
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Overall Study
Not eligible after first screening visit
|
17
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Vortioxetine for Menopausal Depression
Baseline characteristics by cohort
| Measure |
Open-label Vortioxetine
n=27 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Highest Level of Education
Some high school
|
2 Participants
n=5 Participants
|
|
Highest Level of Education
High school or received GED
|
7 Participants
n=5 Participants
|
|
Highest Level of Education
Vocational/training school after high school
|
2 Participants
n=5 Participants
|
|
Highest Level of Education
Some college or Associate Degree
|
8 Participants
n=5 Participants
|
|
Highest Level of Education
Graduated college (BA, BS)
|
7 Participants
n=5 Participants
|
|
Highest Level of Education
Master's Degree
|
1 Participants
n=5 Participants
|
|
Highest Level of Education
Doctoral Degree (PhD, MD, etc.)
|
0 Participants
n=5 Participants
|
|
Employment
Full-or part-time work
|
7 Participants
n=5 Participants
|
|
Employment
Homemaker
|
2 Participants
n=5 Participants
|
|
Employment
Disabled
|
3 Participants
n=5 Participants
|
|
Employment
Not working, unemployed
|
10 Participants
n=5 Participants
|
|
Employment
Student
|
0 Participants
n=5 Participants
|
|
Employment
Volunteer
|
1 Participants
n=5 Participants
|
|
Employment
Retired
|
2 Participants
n=5 Participants
|
|
Employment
Temporary work
|
2 Participants
n=5 Participants
|
|
Marital Status
Married
|
6 Participants
n=5 Participants
|
|
Marital Status
Separated/divorced/widowed
|
8 Participants
n=5 Participants
|
|
Marital Status
Never married/single
|
13 Participants
n=5 Participants
|
|
Marital Status
Decline to answer
|
0 Participants
n=5 Participants
|
|
Menopausal Status
Perimenopausal
|
13 Participants
n=5 Participants
|
|
Menopausal Status
Naturally postmenopausal
|
12 Participants
n=5 Participants
|
|
Menopausal Status
Surgically postmenopausal
|
2 Participants
n=5 Participants
|
|
Past hormone therapy use
Used hormone therapy in the past
|
4 Participants
n=5 Participants
|
|
Past hormone therapy use
Never used hormone therapy in the past
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all 24 participants who initiated medication treatment and returned for at least one assessment after starting vortioxetine. A last observation carried forward (LOCF) analysis was used.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
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|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)
|
-22.8 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=23 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)
|
-1.33 hot flashes per day
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.
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
Outcome measures
| Measure |
Open-label Vortioxetine
n=23 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)
|
-0.28 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=23 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)
|
-1.15 hot flashes per night
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.
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
Outcome measures
| Measure |
Open-label Vortioxetine
n=23 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)
|
-0.27 units on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)
|
-13 units on a scale
Interval -15.0 to -7.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
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|---|---|
|
Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)
|
-7 units on a scale
Interval -12.5 to -0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)
|
-5 units on a scale
Interval -7.5 to -2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)
|
-1.74 units on a scale
Interval -2.61 to -1.3
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)
|
-1 units on a scale
Interval -2.5 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)
|
-1 units on a scale
Interval -2.5 to -1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)
|
-4 units on a scale
Interval -9.5 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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: 1\. 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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)
|
-18.5 units on a scale
Interval -25.0 to -13.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Visit 5)Population: The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.
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.
Outcome measures
| Measure |
Open-label Vortioxetine
n=24 Participants
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)
|
8.5 units on a scale
Interval 4.5 to 15.5
|
Adverse Events
Open-label Vortioxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label Vortioxetine
n=27 participants at risk
Flexible-dose vortioxetine of 5-20 mg depending on tolerability
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.
|
|---|---|
|
General disorders
Nausea
|
48.1%
13/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Nervous system disorders
Headaches
|
25.9%
7/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Dry mouth
|
18.5%
5/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Increased thirst
|
7.4%
2/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Dizziness
|
7.4%
2/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Gastrointestinal disorders
Stomach cramps
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Skin and subcutaneous tissue disorders
Mild rash
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Abdomen tenderness
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Nervous system disorders
Numbness
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Restlessness
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Disrupted sleep
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Difficulty falling asleep
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Decreased appetite
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Increased appetite
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Increased fatigue
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Reproductive system and breast disorders
Decreased libido
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Reproductive system and breast disorders
Anorgasmia
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Cardiac disorders
Palpitations
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
General disorders
Edginess
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Eye disorders
Blurred vision
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
|
Psychiatric disorders
Increased Anxiety
|
3.7%
1/27 • Adverse event data were assessed from baseline through Week 8 (Visit 5) of the study. At each study visit, physician investigators prompted the participant to report any occurrences of health problems other than usual menopause related symptoms. Any serious or non-serious adverse events were recorded in the participant's study binder at each examination.
|
Additional Information
Dr. Marlene Freeman
MGH Center for Women's Mental Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place