Depression
Conditions
Keywords
Depression,, depressive symptoms,, major depressive disorder,, Fevarine,, fluvoxamine,, cognitive function,, neurological disorders,, sleep state
Brief summary
Prospective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.
Interventions
None listed
Sponsors
Manipal Acunova Ltd.
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients with neurological disorders and mild or moderate symptoms of depression with Hospital Anxiety Depression Scale (HADS) depression scale score of 8 and higher. Fevarin® prescribed not earlier than 7 days before Visit 1.
Exclusion criteria
* Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | Baseline | The primary neurologic diagnosis was coded according to International Classification of Diseases and Related Health Problems, revision 10 http://apps.who.int/classifications/icd10/browse/2010/en In the report all diseases were summarized by Classes. Percentage of patients reporting at least once a specified symptom during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Change in Clinical Global Impression Scale | From Baseline up to Day 90 | — |
| Gender | Baseline | — |
| Race | Baseline | — |
| Family Status | Baseline | — |
| Education | Baseline | — |
| Employment | Baseline | — |
| Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | From Baseline up to Day 30 and Day 90 | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score' is presented |
| Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 | From Baseline up to Day 30 | — |
| Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score | From Baseline up to Day 30 and Day 90 | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score' is presented |
| Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale | Baseline, Day 90 | Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients |
| Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS) | Up to 180 days | HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place Change in the Hospital Anxiety and Depression Scale (HADS) Both Subscale Scores are presented assessed at Day 180 |
| Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. | From Baseline up to Day 30 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 | From baseline up to Day 90 | Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90. |
| Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days | From Day 90 up to Up to 180 days | Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients |
| Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | From Day 90 up to 180 days | Global improvement - qualitative scale 0 = Not assessed, 1 = Very much improved , 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse |
| Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) | Baseline, Day 90, Up to 180 days | MoCA test used under license agreement www.mocatest.org Scale range 0-30 Normal \>=26 Higher values represent a better outcome |
| Insomnia Severity Index | Baseline, Day 90, Up to 180 days | Insomnia Severity Index (ISI) used under license agreement cmorin@psy.ulaval.ca Total score has the range from 0 to 28 points with the following categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe). Higher values represent a worse outcome |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Outpatients With Neurological Disorders and Depression. Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label. | 299 |
| Total | 299 |
Baseline characteristics
| Characteristic | Outpatients With Neurological Disorders and Depression. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 245 Participants |
| Age, Continuous | 50.51 years |
| Region of Enrollment Russian Federation | 299 participants |
| Sex: Female, Male Female | 219 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 299 |
| other Total, other adverse events | 22 / 299 |
| serious Total, serious adverse events | 0 / 299 |
Outcome results
Primary
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).
The primary neurologic diagnosis was coded according to International Classification of Diseases and Related Health Problems, revision 10 http://apps.who.int/classifications/icd10/browse/2010/en In the report all diseases were summarized by Classes. Percentage of patients reporting at least once a specified symptom during the treatment period.
Time frame: Baseline
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | International Classification of Diseases G00-G99 | 49.2 Percentage |
| Outpatients With Neurological Disorders and Depression. | Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | International Classification of Diseases I00-I99 | 31.8 Percentage |
| Outpatients With Neurological Disorders and Depression. | Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | International Classification of Diseases M00-M99 | 20.1 Percentage |
| Outpatients With Neurological Disorders and Depression. | Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). | International Classification of Diseases T00-T99 | 2.7 Percentage |
Secondary
Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)
HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place Change in the Hospital Anxiety and Depression Scale (HADS) Both Subscale Scores are presented assessed at Day 180
Time frame: Up to 180 days
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS) | HADS - D | 4.2 units on a scale | Standard Deviation 3.17 |
| Outpatients With Neurological Disorders and Depression. | Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS) | HADS - A | 4.7 units on a scale | Standard Deviation 3.33 |
Secondary
Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale
Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients
Time frame: Baseline, Day 90
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale | -1 units on a scale | Standard Deviation 0.91 |
Secondary
Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score' is presented
Time frame: From Baseline up to Day 30 and Day 90
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score | Baseline Day 90 | -6.5 units on a scale | Standard Deviation 3.62 |
| Outpatients With Neurological Disorders and Depression. | Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score | Baseline Day 30 | -3.4 units on a scale | Standard Deviation 2.78 |
Secondary
Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/ The scale have two subscales: HADS-Anxiety HADS-Depression Each subscale has range 0-21 with following interpretation: 0-7 normal 8-10 mild 11-14 moderate 15-21 severe In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score' is presented
Time frame: From Baseline up to Day 30 and Day 90
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | Baseline Day 30 | -3 units on a scale | Standard Deviation 2.5 |
| Outpatients With Neurological Disorders and Depression. | Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | Baseline Day 90 | -6 units on a scale | Standard Deviation 3.24 |
Secondary
Education
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Education | Elementary | 3 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Education | Secondary | 33.8 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Education | University | 63.2 percentage of participants |
Secondary
Employment
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Employment | Employed | 62.5 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Employment | Unemployed | 37.5 percentage of participants |
Secondary
Family Status
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Family Status | Civil marriage | 1 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Family Status | Divorced | 5.4 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Family Status | Married | 65.9 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Family Status | Single | 15.7 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Family Status | Widow(er) | 12 percentage of participants |
Secondary
Gender
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Gender | Female | 73.24 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Gender | Male | 26.76 percentage of participants |
Secondary
Percent of Patients With Change in Clinical Global Impression Scale
Time frame: From Baseline up to Day 90
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Very much improved | 38.1 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Much improved | 46.9 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Minimaly improved | 11.2 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | No change | 2.4 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Minimaly worse | 0.3 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Much worse | 0.3 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale | Not assessed | 0.7 percentage of participants |
Secondary
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.
Time frame: From Baseline up to Day 30
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. | Improved | 89.9 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. | Worsened | 2.7 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. | No change | 7.4 percentage of participants |
Secondary
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30
Time frame: From Baseline up to Day 30
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 | Improved | 88.2 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 | Worsened | 2.7 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 | No change | 9.1 percentage of participants |
Secondary
Race
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Race | Asian | 0.7 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Race | White | 99.3 percentage of participants |
Other Pre-specified
Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days
Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients
Time frame: From Day 90 up to Up to 180 days
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days | -0.2 units on a scale | Standard Deviation 0.55 |
Other Pre-specified
Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)
MoCA test used under license agreement www.mocatest.org Scale range 0-30 Normal \>=26 Higher values represent a better outcome
Time frame: Baseline, Day 90, Up to 180 days
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) | Baseline | 25.2 units on a scale | Standard Deviation 3.63 |
| Outpatients With Neurological Disorders and Depression. | Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) | Day 90 | 27 units on a scale | Standard Deviation 2.69 |
| Outpatients With Neurological Disorders and Depression. | Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) | Day 180 | 27.5 units on a scale | Standard Deviation 2.42 |
Other Pre-specified
Insomnia Severity Index
Insomnia Severity Index (ISI) used under license agreement cmorin@psy.ulaval.ca Total score has the range from 0 to 28 points with the following categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe). Higher values represent a worse outcome
Time frame: Baseline, Day 90, Up to 180 days
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Insomnia Severity Index | Baseline | 13.4 units on a scale | Standard Deviation 5.52 |
| Outpatients With Neurological Disorders and Depression. | Insomnia Severity Index | Day 90 | 6.6 units on a scale | Standard Deviation 4.32 |
| Outpatients With Neurological Disorders and Depression. | Insomnia Severity Index | Day 180 | 4.5 units on a scale | Standard Deviation 3.98 |
Other Pre-specified
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180
Global improvement - qualitative scale 0 = Not assessed, 1 = Very much improved , 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse
Time frame: From Day 90 up to 180 days
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | Very much improved | 56.9 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | Much improved | 29.3 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | Minimaly improved | 9.6 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | No change | 2.9 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | Minimaly worse | 0.8 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 | Much worse | 0.4 percentage of participants |
Other Pre-specified
Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90
Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90.
Time frame: From baseline up to Day 90
Population: The actual number of assessed patients was provided to each measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 | Improved | 91.5 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 | Worsened | 4.1 percentage of participants |
| Outpatients With Neurological Disorders and Depression. | Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 | No change | 4.4 percentage of participants |