mirtazapine has been researched along with Hot Flashes in 4 studies
Mirtazapine: A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
Hot Flashes: A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed)
| Excerpt | Relevance | Reference |
|---|---|---|
| "In two women with depression a reduction in hot flushes was noticed by serendipity during treatment with mirtazapine 15-30 mg/daily." | 3.70 | Treatment of hot flushes with mirtazapine: four case reports. ( Berendsen, HH; Schweitzer, DH; Waldinger, MD, 2000) |
| "Esmirtazapine was generally well tolerated with a more favorable safety profile at lower doses." | 2.90 | Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials. ( Birkhaeuser, M; Bitzer, J; Braat, S; Ramos, Y, 2019) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 3 (75.00) | 29.6817 |
| 2010's | 1 (25.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Birkhaeuser, M | 1 |
| Bitzer, J | 1 |
| Braat, S | 1 |
| Ramos, Y | 1 |
| Albertazzi, P | 1 |
| Pawlyk, AC | 1 |
| Cosmi, S | 1 |
| Alfinito, PD | 1 |
| Maswood, N | 1 |
| Deecher, DC | 1 |
| Waldinger, MD | 1 |
| Berendsen, HH | 1 |
| Schweitzer, DH | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Four Different Doses of Org 50081 in the Treatment of Moderate to Severe Vasomotor Symptoms Associated With the Menopause[NCT00560833] | Phase 3 | 943 participants (Actual) | Interventional | 2004-10-15 | Completed | ||
| A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Four Different Doses of Org 50081 in the Treatment of Moderate to Severe Vasomotor Symptoms Associated With the Menopause[NCT00535288] | Phase 3 | 946 participants (Actual) | Interventional | 2004-09-15 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00560833)
Timeframe: Baseline and Week 12
| Intervention | number of events (Mean) |
|---|---|
| Placebo | -4.9 |
| Esmirtazapine 2.25 mg | -6.2 |
| Esmirtazapine 4.5 mg | -6.7 |
| Esmirtazapine 9 mg | -6.9 |
| Esmirtazapine 18mg | -6.5 |
Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00560833)
Timeframe: Baseline and Week 4
| Intervention | Number of events (Mean) |
|---|---|
| Placebo | -3.9 |
| Esmirtazapine 2.25 mg | -5.6 |
| Esmirtazapine 4.5 mg | -6.0 |
| Esmirtazapine 9 mg | -6.0 |
| Esmirtazapine 18mg | -6.0 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00560833)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | -0.12 |
| Esmirtazapine 2.25 mg | -0.10 |
| Esmirtazapine 4.5 mg | -0.15 |
| Esmirtazapine 9 mg | -0.18 |
| Esmirtazapine 18mg | -0.17 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00560833)
Timeframe: Baseline and Week 4
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | -0.09 |
| Esmirtazapine 2.25 mg | -0.11 |
| Esmirtazapine 4.5 mg | -0.15 |
| Esmirtazapine 9 mg | -0.16 |
| Esmirtazapine 18mg | -0.15 |
The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better. (NCT00560833)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline | |
| Esmirtazapine 18mg | 0.985 | -0.246 |
| Esmirtazapine 2.25 mg | 0.993 | -0.235 |
| Esmirtazapine 4.5 mg | 0.985 | -0.256 |
| Esmirtazapine 9 mg | 0.981 | -0.256 |
| Placebo | 0.984 | -0.151 |
Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score B was based on the number of mild hot flushes + the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and up to Week 12
| Intervention | Events per day (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 13.00 | -4.16 | -5.50 | -5.79 | -5.85 | -5.90 | -5.89 | -6.15 | -6.03 | -6.26 | -6.35 | -6.28 | -6.32 |
| Esmirtazapine 2.25 mg | 13.48 | -3.24 | -4.81 | -5.05 | -5.37 | -5.61 | -5.82 | -5.69 | -5.54 | -5.47 | -5.59 | -5.68 | -5.63 |
| Esmirtazapine 4.5 mg | 13.66 | -3.81 | -5.19 | -5.66 | -6.01 | -6.13 | -6.32 | -6.47 | -6.51 | -6.59 | -6.36 | -6.45 | -6.45 |
| Esmirtazapine 9 mg | 13.41 | -3.57 | -4.79 | -5.08 | -5.38 | -5.57 | -5.75 | -5.90 | -6.06 | -6.08 | -6.18 | -6.08 | -6.10 |
| Placebo | 13.29 | -2.22 | -3.35 | -3.83 | -3.97 | -4.06 | -4.25 | -4.27 | -4.19 | -4.30 | -4.29 | -4.43 | -4.40 |
Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and Week 12
| Intervention | Events per day (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Esmirtazapine 18 mg | 11.5 | -6.0 |
| Esmirtazapine 2.25 mg | 12.2 | -5.2 |
| Esmirtazapine 4.5 mg | 12.6 | -6.0 |
| Esmirtazapine 9 mg | 12.3 | -5.8 |
| Placebo | 12.1 | -4.2 |
Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and Week 4
| Intervention | Events per day (Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Esmirtazapine 18 mg | 11.5 | -5.6 |
| Esmirtazapine 2.25 mg | 12.2 | -5.1 |
| Esmirtazapine 4.5 mg | 12.6 | -5.7 |
| Esmirtazapine 9 mg | 12.3 | -5.3 |
| Placebo | 12.1 | -3.8 |
Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and Up to Week 12
| Intervention | Events per day (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | |
| Esmirtazapine 18 mg | 11.52 | -4.18 | -5.39 | -5.59 | -5.54 | -5.62 | -5.93 | -5.72 | -5.95 | -6.11 | -5.91 |
| Esmirtazapine 2.25 mg | 12.19 | -3.20 | -4.72 | -4.82 | -5.29 | -5.41 | -5.33 | -5.19 | -5.15 | -5.18 | -5.30 |
| Esmirtazapine 4.5 mg | 12.56 | -4.08 | -5.19 | -5.68 | -5.83 | -5.96 | -6.10 | -6.14 | -6.23 | -5.97 | -6.03 |
| Esmirtazapine 9 mg | 12.30 | -3.63 | -4.88 | -5.13 | -5.50 | -5.58 | -5.69 | -5.86 | -5.96 | -6.00 | -5.86 |
| Placebo | 12.10 | -2.21 | -3.25 | -3.71 | -3.90 | -4.02 | -4.11 | -4.04 | -4.11 | -4.11 | -4.20 |
Composite Score B was calculated as Severity Score B x Frequency Score B. (NCT00535288)
Timeframe: Baseline and up to Week 12
| Intervention | Composite score (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 29.35 | -10.61 | -13.64 | -14.09 | -14.01 | -14.08 | -14.21 | -14.93 | -14.40 | -14.98 | -15.32 | -14.95 | -15.04 |
| Esmirtazapine 2.25 mg | 31.70 | -8.53 | -12.40 | -12.86 | -13.48 | -13.96 | -14.29 | -14.09 | -13.66 | -13.53 | -13.71 | -13.96 | -13.66 |
| Esmirtazapine 4.5 mg | 32.13 | -10.01 | -12.98 | -14.40 | -14.69 | 014.78 | -15.19 | -15.48 | -15.56 | -15.77 | -15.15 | -15.34 | -15.32 |
| Esmirtazapine 9 mg | 31.51 | -9.37 | -12.60 | -13.34 | -13.75 | -14.22 | -14.40 | -14.63 | -14.92 | -15.05 | -15.21 | -14.79 | -14.71 |
| Placebo | 31.39 | -5.66 | -8.38 | -9.57 | -9.93 | -10.12 | -10.45 | -10.58 | -10.34 | -10.49 | -10.44 | -10.76 | -10.66 |
Composite Score A was calculated as Severity Score A x Frequency Score A. (NCT00535288)
Timeframe: Baseline and up to Week 12
| Intervention | Composite score (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 27.87 | -10.63 | -13.54 | -13.89 | -13.72 | -13.72 | -13.95 | -14.72 | -14.08 | -14.67 | -15.08 | 14.57 | -14.71 |
| Esmirtazapine 2.25 mg | 30.41 | -8.48 | -12.32 | -12.63 | -13.18 | -13.65 | -13.89 | -13.73 | -13.31 | -13.20 | -13.30 | -13.58 | -13.25 |
| Esmirtazapine 4.5 mg | 31.03 | -10.28 | -12.98 | -14.22 | -14.42 | -14.47 | -14.84 | -15.11 | -15.19 | -15.40 | -14.76 | -14.92 | -14.88 |
| Esmirtazapine 9 mg | 30.40 | -9.43 | -12.70 | -13.39 | -13.70 | -14.16 | -14.24 | -14.42 | -14.73 | -14.93 | -15.03 | -14.58 | -14.36 |
| Placebo | 30.19 | -5.65 | -8.28 | -9.46 | -9.79 | -9.96 | -10.22 | -10.42 | -10.20 | -10.30 | -10.26 | -10.53 | -10.42 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score B was calculated as the number of mild hot flushes + the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of all hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and up to Week 12
| Intervention | Severity score (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 2.270 | -0.192 | -0.250 | -0.272 | -0.273 | -0.266 | -0.275 | -0.287 | -0.273 | -0.292 | -0.307 | -0.308 | -0.280 |
| Esmirtazapine 2.25 mg | 2.331 | -0.132 | -0.210 | -0.217 | -0.224 | -0.234 | -0.222 | -0.234 | -0.251 | -0.245 | -0.244 | -0.260 | -0.255 |
| Esmirtazapine 4.5 mg | 2.349 | -0.167 | -0.223 | -0.246 | -0.240 | -0.228 | -0.214 | -0.232 | -0.234 | -0.256 | -0.257 | -0.245 | -0.240 |
| Esmirtazapine 9 mg | 2.350 | -0.140 | -0.225 | -0.240 | -0.249 | -0.254 | -0.245 | -0.242 | -0.251 | -0.256 | -0.257 | -0.224 | -0.210 |
| Placebo | 2.332 | -0.080 | -0.111 | -0.121 | -0.113 | -0.124 | -0.121 | -0.142 | -0.139 | -0.136 | -0.143 | -0.149 | -0.152 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and Week 12
| Intervention | Severity score (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Esmirtazapine 18 mg | 2.40 | -0.15 |
| Esmirtazapine 2.25 mg | 2.45 | -0.15 |
| Esmirtazapine 4.5 mg | 2.45 | -0.13 |
| Esmirtazapine 9 mg | 2.46 | -0.13 |
| Placebo | 2.45 | -0.08 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and Week 4
| Intervention | Severity score (Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Esmirtazapine 18 mg | 2.40 | -0.15 |
| Esmirtazapine 2.25 mg | 2.45 | -0.14 |
| Esmirtazapine 4.5 mg | 2.45 | -0.13 |
| Esmirtazapine 9 mg | 2.46 | -0.15 |
| Placebo | 2.45 | -0.07 |
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward. (NCT00535288)
Timeframe: Baseline and up to Week 12
| Intervention | Severity score (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 3 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | |
| Esmirtazapine 18 mg | 2.400 | -0.108 | -0.136 | -0.137 | -0.151 | -0.152 | -0.144 | -0.133 | -0.144 | -0.162 | -0.156 |
| Esmirtazapine 2.25 mg | 2.451 | -0.081 | -0.117 | -0.133 | -0.141 | -0.136 | -0.144 | -0.142 | -0.142 | -0.147 | -0.159 |
| Esmirtazapine 4.5 mg | 2.449 | -0.085 | -0.111 | -0.119 | -0.123 | -0.127 | -0.131 | -0.124 | -0.137 | -0.125 | -0.130 |
| Esmirtazapine 9 mg | 2.460 | -0.085 | -0.140 | -0.150 | -0.154 | -0.140 | -0.140 | -0.139 | -0.130 | -0.141 | -0.124 |
| Placebo | 2.447 | -0.045 | -0.063 | -0.071 | -0.080 | -0.075 | -0.088 | -0.082 | -0.083 | -0.084 | -0.078 |
The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better. (NCT00535288)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Esmirtazapine 18mg | 0.984 | -0.164 |
| Esmirtazapine 2.25 mg | 0.989 | -0.196 |
| Esmirtazapine 4.5 mg | 0.993 | -0.224 |
| Esmirtazapine 9 mg | 0.984 | -0.117 |
| Placebo | 0.983 | -0.085 |
The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Sleep problems encompass Items 1, 11, and 29 of the 36 total items. The transformed sums of items 1, 11, and 29 were divided by 3 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better. (NCT00535288)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Esmirtazapine 18 mg | 0.693 | -0.195 |
| Esmirtazapine 2.25 mg | 0.659 | -0.232 |
| Esmirtazapine 4.5 mg | 0.684 | -0.251 |
| Esmirtazapine 9 mg | 0.688 | -0.224 |
| Placebo | 0.714 | -0.140 |
A participant was defined as a (hot flush) remitter for a study week if at most one moderate/severe vasomotor symptom per day on average was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-remitter. (NCT00535288)
Timeframe: Up to 12 weeks
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 2 | 13 | 17 | 17 | 17 | 18 | 21 | 21 | 26 | 25 | 28 | 26 |
| Esmirtazapine 2.25 mg | 2 | 11 | 15 | 15 | 18 | 15 | 19 | 19 | 19 | 19 | 22 | 23 |
| Esmirtazapine 4.5 mg | 7 | 13 | 16 | 18 | 16 | 21 | 22 | 25 | 25 | 25 | 23 | 24 |
| Esmirtazapine 9 mg | 2 | 8 | 7 | 15 | 12 | 13 | 16 | 18 | 19 | 23 | 21 | 20 |
| Placebo | 3 | 6 | 8 | 10 | 13 | 15 | 19 | 23 | 24 | 25 | 25 | 27 |
A participant was defined as a (hot flush) responder for a study week if a reduction of at least 50% for average daily frequency of moderate/severe vasomotor symptoms (hot flushes) (Frequency Score A) compared to Baseline was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-responder. An LOCF approach was used. (NCT00535288)
Timeframe: Up to 12 weeks
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | |
| Esmirtazapine 18 mg | 42 | 65 | 72 | 71 | 71 | 69 | 75 | 72 | 75 | 77 | 72 | 77 |
| Esmirtazapine 2.25 mg | 29 | 49 | 53 | 58 | 63 | 67 | 59 | 65 | 67 | 65 | 70 | 70 |
| Esmirtazapine 4.5 mg | 35 | 60 | 63 | 70 | 65 | 70 | 72 | 73 | 74 | 73 | 78 | 75 |
| Esmirtazapine 9 mg | 32 | 48 | 47 | 52 | 56 | 55 | 60 | 66 | 68 | 67 | 65 | 65 |
| Placebo | 37 | 56 | 85 | 76 | 76 | 84 | 89 | 93 | 96 | 97 | 95 | 99 |
1 review available for mirtazapine and Hot Flashes
| Article | Year |
|---|---|
Noradrenergic and serotonergic modulation to treat vasomotor symptoms.
Topics: Citalopram; Cyclohexanols; Female; Fluoxetine; Hot Flashes; Humans; Menopause; Mianserin; Mirtazapin | 2006 |
1 trial available for mirtazapine and Hot Flashes
| Article | Year |
|---|---|
Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.
Topics: Adult; Aged; Antidepressive Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; H | 2019 |
Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.
Topics: Adult; Aged; Antidepressive Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; H | 2019 |
Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.
Topics: Adult; Aged; Antidepressive Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; H | 2019 |
Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.
Topics: Adult; Aged; Antidepressive Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; H | 2019 |
2 other studies available for mirtazapine and Hot Flashes
| Article | Year |
|---|---|
Effects of the 5-HT2A antagonist mirtazapine in rat models of thermoregulation.
Topics: Animals; Body Temperature Regulation; Dose-Response Relationship, Drug; Female; Hot Flashes; Mianser | 2006 |
Treatment of hot flushes with mirtazapine: four case reports.
Topics: Adult; Antidepressive Agents, Tricyclic; Depression; Female; Hot Flashes; Humans; Mianserin; Middle | 2000 |