Ischemic Stroke, Mild Cognitive Impairment
Conditions
Brief summary
The purpose of this study is: * to evaluate efficacy of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke * to evaluate safety of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke
Detailed description
A double-blind, placebo-controlled randomized clinical trial in parallel groups. The study patients are subjects of either gender, aged 45-80 years old, after an ischemic stroke within 3-6 months prior to enrollment and confirmed by neuroimaging, having mild cognitive impairment. After the patients provide signed Participant Information Sheet and Informed Consent, they will be interviewed for complaints and medical history and undergo physical examination and laboratory tests. The doctor will rate the severity of patients' cognitive impairments on the Mini Mental State Examination (MMSE) scale and Montreal Cognitive Assessment (MoCA) scale, assess their performance in activities of daily living on the Barthel Index scale \[Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disability Study.1988;10:61-63.\], and administer the Stroke Specific Quality of Life Scale (SS-QOL) questionnaire \[Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke 1999 Jul;30(7):1362-9\]. Eligible participants will have to have moderate cognitive impairments (MMSE score - at least 21 and MoCA - less than 26). Therapy received by patients for their co-morbidities and primary diagnosis will be recorded. All women of childbearing potential will be administered pregnancy tests. If a patient meets all inclusion criteria and does not have any exclusion criteria at Visit 1, he/she is randomized to one of the two groups: group 1 will receive MMH-MAP at 2 tablets twice daily; group 2 will receive Placebo using the study product dosing regimen. The total duration of follow-up and treatment will be 28 weeks, which will include 5 additional visits. At Visit 2 (Week 4±7 days), the doctor records patients' complaints and physical examination data, reviews the progress of study and basic and concomitant therapy, and assesses treatment safety and patient compliance with treatment. At Visit 3 (Week 8±7 days), Visit 4 (Week 16±7 days), and Visit 5 (Week 24±7 days), the doctor assesses patients' cognitive impairments (MoCA) and performance in activities of daily living (the Barthel Index). The patients complete the SS-QOL questionnaire. At Visit 5 (Week 24±7 days), the doctor will additionally complete the Clinical Global Impression Efficacy Index (CGI-EI) scale \[Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976 Rockville, MD, U.S. Department of Health, Education, and Welfare\] and collect samples for laboratory testing. The patient stops taking the study drug. After four weeks following the end of study therapy patients complete a follow-up visit -Visit 6 (Week 28±7 days). The patients are interviewed for complaints and undergo physical examination, with a check on their concomitant and primary therapies as well as on the safety of study treatment. The doctor assesses patients' cognitive impairments (MoCA) and performance in activities of daily living (the Barthel Index) and administers the SS-QOL questionnaire. The total length of the observation period will be 28 weeks. During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section Prohibited Concomitant Treatment.
Interventions
DRUGMMH-MAP
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of either sex, aged 45 to 80 years old inclusively. 2. Patients with a history of one stroke sustained 3 to 6 months prior to study entry and confirmed by neuroimaging. 3. Patients with cognitive impairment (MoCA score \< 26). 4. Patients with moderate performance in activities of daily living (Barthel score = 61-80). 5. Agreement to use a reliable method of birth control for the duration of the study (men and women of reproductive potential). 6. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Exclusion criteria
1. Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition which has caused neurological dysfunction. 2. History of central nervous system (CNS) disorders, including: * inflammatory diseases of the CNS (G00-G09) * systemic atrophies primarily affecting the CNS (G10-G13) * extrapyramidal and movement disorders (G20-G26) * other degenerative diseases of the nervous system (G30-G32) * demyelinating diseases of the CNS (G35-G37) * epilepsy (G40-41) * polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders * diseases of neuromuscular junction and muscle (G70-73) * hydrocephalus (G91) * compression of brain (G93.5). 3. Dementia (20 or less on the MMSE score). 4. Speech disorders affecting investigator-patient communication. 5. Prior diagnosis of heart failure defined by the New York Heart Association classification (1964) as IV Functional Classification or poorly treated hypothyroidism or diabetes mellitus. 6. Patients having unstable angina or myocardial infarction in the past 6 months. 7. History/suspicion of oncology of any location (except for benign neoplasms). 8. Any other co-morbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial. 9. Patients allergic to/intolerant of any components of the study treatment. 10. Patients with hereditary lactose intolerance. 11. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia. 12. Pregnancy, breast-feeding or unwillingness to use birth control during the study. 13. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens. 14. Patients with a history of non-adherence to medication; mental disorder (except for cognitive deficits); or alcoholism or abuse of psychoactive substances, which, in the investigator's opinion, will compromise compliance with study procedures. 15. Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the past week. 16. Participation in other clinical trials in the previous 3 months. 17. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). 18. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More) | 24 weeks of the treatment as compared to the baseline | MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More) | 24 weeks of the treatment as compared to the baseline | Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome. |
| Change in Barthel Index Score | 24 weeks of the treatment as compared to the baseline | Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome. |
| Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | 24 weeks of the treatment as compared to the baseline | Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains. Each domain consists of 3 to 10 items that are averaged to generate an overall score. Total score minimum value is 1 and maximum value is 245. Higher values represent a better outcome. |
| Change in MoCA (The Montreal Cognitive Assessment Test) Score | 24 weeks of the treatment as compared to the baseline | MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. |
| Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | 24 and 28 weeks of the study | Test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. |
| Change in Barthel Index Score During Follow-up | 24 and 28 weeks of the study | Scale for measurement of performance in activities of daily living (ADL). The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome. |
| Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | 24 and 28 weeks of the study | Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains.Each domain consists of 3 to 10 items that are averaged to generate an overall score.Total score minimum value is 1 and maximum value is 245.Higher values represent a better outcome. |
| The CGI-EI (Clinical Global Impression Efficacy Index) Score | 24 weeks of the treatment | Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result. |
Countries
Russia
Participant flow
Pre-assignment details
In total, 276 patients signed informed consent. After screening procedures, data from 1 patient did not meet the inclusion / exclusion criteria. The study randomized 275 patients.
Participants by arm
| Arm | Count |
|---|---|
| MMH-MAP Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
MMH-MAP: Oral administration | 135 |
| Placebo Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
Placebo: Oral administration | 140 |
| Total | 275 |
Baseline characteristics
| Characteristic | Placebo | Total | MMH-MAP |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 8.5 | 64.0 years STANDARD_DEVIATION 8.1 | 64.5 years STANDARD_DEVIATION 7.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 140 participants | 275 participants | 135 participants |
| Sex: Female, Male Female | 62 Participants | 124 Participants | 62 Participants |
| Sex: Female, Male Male | 78 Participants | 151 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 1 / 140 |
| other Total, other adverse events | 37 / 135 | 39 / 140 |
| serious Total, serious adverse events | 4 / 135 | 3 / 140 |
Outcome results
Primary
Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)
MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Time frame: 24 weeks of the treatment as compared to the baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More) | 124 Participants |
| Placebo | Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More) | 115 Participants |
p-value: 0.02Fisher Exact
Other Pre-specified
Change in Barthel Index Score
Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Time frame: 24 weeks of the treatment as compared to the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in Barthel Index Score | Baseline | 74.7 score on a scale | Standard Deviation 5.4 |
| MMH-MAP | Change in Barthel Index Score | After 24 weeks | 89.7 score on a scale | Standard Deviation 8.7 |
| MMH-MAP | Change in Barthel Index Score | ∆ between baseline and after 24 weeks | 14.9 score on a scale | Standard Deviation 8.8 |
| Placebo | Change in Barthel Index Score | Baseline | 74.8 score on a scale | Standard Deviation 5.7 |
| Placebo | Change in Barthel Index Score | After 24 weeks | 86.6 score on a scale | Standard Deviation 11.3 |
| Placebo | Change in Barthel Index Score | ∆ between baseline and after 24 weeks | 12.2 score on a scale | Standard Deviation 10.4 |
Comparison: This analysis applies to ∆ between baseline and after 24 weeks total scores row.p-value: 0.04Wilcoxon (Mann-Whitney)
Other Pre-specified
Change in Barthel Index Score During Follow-up
Scale for measurement of performance in activities of daily living (ADL). The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Time frame: 24 and 28 weeks of the study
Population: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in Barthel Index Score During Follow-up | After 24 weeks | 89.7 score on a scale | Standard Deviation 8.7 |
| MMH-MAP | Change in Barthel Index Score During Follow-up | After 28 weeks | 90.6 score on a scale | Standard Deviation 10.9 |
| MMH-MAP | Change in Barthel Index Score During Follow-up | ∆ between 24 and 28 weeks | 1.5 score on a scale | Standard Deviation 3.1 |
| Placebo | Change in Barthel Index Score During Follow-up | After 24 weeks | 86.6 score on a scale | Standard Deviation 11.3 |
| Placebo | Change in Barthel Index Score During Follow-up | After 28 weeks | 87.4 score on a scale | Standard Deviation 10.1 |
| Placebo | Change in Barthel Index Score During Follow-up | ∆ between 24 and 28 weeks | 0.6 score on a scale | Standard Deviation 3.1 |
Comparison: This analysis applies to ∆ between 24 and 28 weeks total scores row.p-value: 0.0118Wilcoxon (Mann-Whitney)
Other Pre-specified
Change in MoCA (The Montreal Cognitive Assessment Test) Score
MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Time frame: 24 weeks of the treatment as compared to the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score | Baseline | 19.4 score on a scale | Standard Deviation 2.3 |
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score | After 24 weeks | 23.3 score on a scale | Standard Deviation 2.7 |
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score | ∆ between baseline and after 24 weeks | 3.8 score on a scale | Standard Deviation 2.4 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score | Baseline | 19.2 score on a scale | Standard Deviation 2.5 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score | After 24 weeks | 22.5 score on a scale | Standard Deviation 3 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score | ∆ between baseline and after 24 weeks | 3.1 score on a scale | Standard Deviation 2.9 |
Comparison: This analysis applies to ∆ between baseline and after 24 weeks total scores row.p-value: 0.0445Wilcoxon (Mann-Whitney)
Other Pre-specified
Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up
Test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Time frame: 24 and 28 weeks of the study
Population: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | After 24 weeks | 23.3 score on a scale | Standard Deviation 2.7 |
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | After 28 weeks | 23.6 score on a scale | Standard Deviation 3.1 |
| MMH-MAP | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | ∆ between 24 and 28 weeks | 0.4 score on a scale | Standard Deviation 1.3 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | After 24 weeks | 22.5 score on a scale | Standard Deviation 3 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | After 28 weeks | 22.7 score on a scale | Standard Deviation 3.1 |
| Placebo | Change in MoCA (The Montreal Cognitive Assessment Test) Score During Follow-up | ∆ between 24 and 28 weeks | 0.3 score on a scale | Standard Deviation 1.4 |
Comparison: This analysis applies to ∆ between 24 and 28 weeks total scores row.p-value: 0.77Wilcoxon (Mann-Whitney)
Other Pre-specified
Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score
Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains. Each domain consists of 3 to 10 items that are averaged to generate an overall score. Total score minimum value is 1 and maximum value is 245. Higher values represent a better outcome.
Time frame: 24 weeks of the treatment as compared to the baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | Baseline | 155.6 score on a scale | Standard Deviation 33 |
| MMH-MAP | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | After 24 weeks | 184.2 score on a scale | Standard Deviation 35.3 |
| MMH-MAP | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | ∆ between baseline and after 24 weeks | 27.9 score on a scale | Standard Deviation 26.1 |
| Placebo | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | Baseline | 156.6 score on a scale | Standard Deviation 32.6 |
| Placebo | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | After 24 weeks | 173.7 score on a scale | Standard Deviation 38 |
| Placebo | Change in SS-QOL (Stroke Specific Quality of Life Scale) Total Score | ∆ between baseline and after 24 weeks | 17.5 score on a scale | Standard Deviation 26.5 |
Comparison: This analysis applies to ∆ between baseline and after 24 weeks total scores row.p-value: 0.0016t-test, 2 sided
Other Pre-specified
Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up
Scale for assessment of health-related quality of life. The scale consists of 49 items in the 12 domains.Each domain consists of 3 to 10 items that are averaged to generate an overall score.Total score minimum value is 1 and maximum value is 245.Higher values represent a better outcome.
Time frame: 24 and 28 weeks of the study
Population: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | After 24 weeks | 184.2 score on a scale | Standard Deviation 35.3 |
| MMH-MAP | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | After 28 weeks | 187.8 score on a scale | Standard Deviation 37.7 |
| MMH-MAP | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | ∆ between 24 and 28 weeks | 4.1 score on a scale | Standard Deviation 9.5 |
| Placebo | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | After 24 weeks | 173.7 score on a scale | Standard Deviation 38 |
| Placebo | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | After 28 weeks | 174.7 score on a scale | Standard Deviation 38 |
| Placebo | Change in Total SS-QOL (Stroke Specific Quality of Life Scale) Score During Follow-up | ∆ between 24 and 28 weeks | 2.8 score on a scale | Standard Deviation 10.2 |
Comparison: This analysis applies to ∆ between 24 and 28 weeks total scores row.p-value: 0.058Wilcoxon (Mann-Whitney)
Other Pre-specified
Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More)
Scale for measurement of performance in activities of daily living (ADL).The maximum score is 100. A score of 91-99 stands for mild dependence in ADL performance, 61-90 - for moderate dependence in ADL performance, 21-60 - for severe dependence in ADL performance, 0-20 - for complete dependence in ADL performance. Higher values represent a better outcome.
Time frame: 24 weeks of the treatment as compared to the baseline
Population: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMH-MAP | Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More) | 118 Participants |
| Placebo | Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More) | 102 Participants |
p-value: 0.0345Fisher Exact
Other Pre-specified
The CGI-EI (Clinical Global Impression Efficacy Index) Score
Rating scale for assessment of the therapeutic effect of treatment and associated side effects. The scale consists of 2 items: therapeutic effect and side effects. Scores in therapeutic effect range from 1 (marked improvement) to 13 (unchanged or worse). Scores in side effects range from 0 (no side effects) to 3 (side effects outweigh therapeutic effects). Efficacy index ranges between 0 and 16. Higher values represent a worse result.
Time frame: 24 weeks of the treatment
Population: According to this criterion, data were obtained for 131 patients of the MMH-MAP group and 127 patients of the Placebo group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMH-MAP | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Therapeutic effect | 5.7 score on a scale | Standard Deviation 3.3 |
| MMH-MAP | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Side effects | 0.1 score on a scale | Standard Deviation 0.4 |
| MMH-MAP | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Efficacy index | 5.8 score on a scale | Standard Deviation 3.4 |
| Placebo | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Therapeutic effect | 6.9 score on a scale | Standard Deviation 3.4 |
| Placebo | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Side effects | 0.1 score on a scale | Standard Deviation 0.4 |
| Placebo | The CGI-EI (Clinical Global Impression Efficacy Index) Score | Efficacy index | 7.0 score on a scale | Standard Deviation 3.4 |
Comparison: This analysis applies to Therapeutic effect row.p-value: 0.0054Wilcoxon (Mann-Whitney)
Comparison: This analysis applies to Side effects row.p-value: 0.78Wilcoxon (Mann-Whitney)
Comparison: This analysis applies to Efficiency index row.p-value: 0.0042Wilcoxon (Mann-Whitney)