Trial Outcomes & Findings for Homeopathic Treatment for Depression in Peri- and Postmenopausal Women (NCT NCT01635218)
NCT ID: NCT01635218
Last Updated: 2014-10-09
Results Overview
17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression).
COMPLETED
PHASE2
133 participants
Baseline and 6 weeks
2014-10-09
Participant Flow
The study was conducted in a public, academic and research hospital in Mexico City. Participants were recruited since March 2012 until December 2013. The recruitment methods included advertisements through internet, community groups,liaisons with health professionals, posters and brochures distributed among hospital population.
Five hundred thirty-four women seeking medical care for menopausal complaints were interviewed and screened. Four hundred and one women did not meet inclusion criteria and were excluded: no depression (44), mild depression (150), severe depression and/or attempt of suicide (43), did not meet other inclusion criteria (164).
Participant milestones
| Measure |
Individualized Homeopathic Treatment
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
43
|
|
Overall Study
COMPLETED
|
41
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
6
|
Reasons for withdrawal
| Measure |
Individualized Homeopathic Treatment
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
6
|
Baseline Characteristics
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
49.2 years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
48.8 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
49 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Mexico
|
44 participants
n=99 Participants
|
46 participants
n=107 Participants
|
43 participants
n=206 Participants
|
133 participants
n=7 Participants
|
|
Baseline score in 17-item Hamilton Rating Scale for Depression
|
21.2 Units in Hamilton Scale
STANDARD_DEVIATION 2.7 • n=99 Participants
|
20.6 Units in Hamilton Scale
STANDARD_DEVIATION 2.9 • n=107 Participants
|
20.7 Units in Hamilton Scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
20.8 Units in Hamilton Scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
|
Baseline score in Beck Depression Inventory
|
26.3 Units in Beck Depression Inventory
STANDARD_DEVIATION 7.2 • n=99 Participants
|
25.0 Units in Beck Depression Inventory
STANDARD_DEVIATION 7.8 • n=107 Participants
|
27.0 Units in Beck Depression Inventory
STANDARD_DEVIATION 9.0 • n=206 Participants
|
26.1 Units in Beck Depression Inventory
STANDARD_DEVIATION 8.0 • n=7 Participants
|
|
Baseline score in Greene Climacteric Scale
|
35.3 Units in Greene Climacteric Scale
STANDARD_DEVIATION 8.5 • n=99 Participants
|
33.5 Units in Greene Climacteric Scale
STANDARD_DEVIATION 10.1 • n=107 Participants
|
37.9 Units in Greene Climacteric Scale
STANDARD_DEVIATION 11.5 • n=206 Participants
|
35.5 Units in Greene Climacteric Scale
STANDARD_DEVIATION 10.2 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.
17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression).
Outcome measures
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.
|
9.9 Units in Hamilton Scale
Standard Deviation 3
|
11.7 Units in Hamilton Scale
Standard Deviation 3.7
|
15 Units in Hamilton Scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.
Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), \> 29 (severe depression).
Outcome measures
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Change From Baseline in Beck Depression Inventory at 6 Weeks.
|
12 Units in Beck Depression Inventory
Standard Deviation 6.1
|
14.2 Units in Beck Depression Inventory
Standard Deviation 7.8
|
15.5 Units in Beck Depression Inventory
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.
Outcome measures
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Responder Rates at 6 Weeks.
|
24 participants with a decrease >50% in HS
|
19 participants with a decrease >50% in HS
|
5 participants with a decrease >50% in HS
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.
Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and \> 50 (severe symptoms).
Outcome measures
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Change From Baseline in Greene´s Scale at 6 Weeks.
|
18.1 Units in Green Scale
Standard Deviation 7.8
|
23.1 Units in Green Scale
Standard Deviation 12.3
|
26.8 Units in Green Scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.
17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score \< or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), \> 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score \< 7 points after 6 weeks of treatment.
Outcome measures
| Measure |
Individualized Homeopathic Treatment
n=44 Participants
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 Participants
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
|
Placebo
n=43 Participants
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Remission Rates at 6 Weeks
|
7 participants with a score of < 7 in HS
|
7 participants with a score of < 7 in HS
|
2 participants with a score of < 7 in HS
|
Adverse Events
Individualized Homeopathic Treatment
Fluoxetine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Individualized Homeopathic Treatment
n=44 participants at risk
Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.
Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
|
Fluoxetine
n=46 participants at risk
Selective serotonin reuptake inhibitor.
Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4.
|
Placebo
n=43 participants at risk
Fluoxetine placebo plus individualized homeopathic placebo
Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
6/44 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
2.2%
1/46 • Number of events 1 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
14.0%
6/43 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
5/44 • Number of events 5 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
4.3%
2/46 • Number of events 2 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
4.7%
2/43 • Number of events 2 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
8.7%
4/46 • Number of events 4 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
14.0%
6/43 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44 • Number of events 3 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
6.5%
3/46 • Number of events 3 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
7.0%
3/43 • Number of events 3 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Nervous system disorders
Headache
|
6.8%
3/44 • Number of events 3 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
13.0%
6/46 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
11.6%
5/43 • Number of events 5 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Psychiatric disorders
Insomnia
|
13.6%
6/44 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
10.9%
5/46 • Number of events 5 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
14.0%
6/43 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
Psychiatric disorders
Anxiety
|
9.1%
4/44 • Number of events 4 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
17.4%
8/46 • Number of events 8 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
4.7%
2/43 • Number of events 2 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
General disorders
Dizziness
|
9.1%
4/44 • Number of events 4 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
10.9%
5/46 • Number of events 5 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
9.3%
4/43 • Number of events 4 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
|
General disorders
Fatigue
|
11.4%
5/44 • Number of events 5 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
8.7%
4/46 • Number of events 4 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
14.0%
6/43 • Number of events 6 • During study duration and 2 weeks after the final dose (8 weeks).
Daily patient's questionnaire and medical examination at each follow-up.
|
Additional Information
Dr. Emma del Carmen Macías-Cortés
Hospital Juárez de México
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place