Trial Outcomes & Findings for Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder (NCT NCT02043197)

NCT ID: NCT02043197

Last Updated: 2018-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 300 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2018-12-17

Participant Flow

Participant milestones

Measure	Outpatients With Neurological Disorders and Depression. Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Overall Study STARTED	300
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder

Baseline characteristics by cohort

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	245 Participants n=5 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants
Age, Continuous	50.51 years n=5 Participants
Sex: Female, Male Female	219 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Region of Enrollment Russian Federation	299 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The actual number of assessed patients was provided to each measure.

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.

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). International Classification of Diseases G00-G99	49.2 Percentage Interval 43.4 to 55.0
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). International Classification of Diseases I00-I99	31.8 Percentage Interval 26.5 to 37.4
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). International Classification of Diseases M00-M99	20.1 Percentage Interval 15.7 to 25.1
Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). International Classification of Diseases T00-T99	2.7 Percentage Interval 1.2 to 5.2

SECONDARY outcome

Timeframe: From Baseline up to Day 30 and Day 90

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Baseline Day 90	-6 units on a scale Standard Deviation 3.24
Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score Baseline Day 30	-3 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: From Baseline up to Day 30

Population: The actual number of assessed patients was provided to each measure.

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 Improved	88.2 percentage of participants
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 Worsened	2.7 percentage of participants
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30 No change	9.1 percentage of participants

SECONDARY outcome

Timeframe: From Baseline up to Day 30 and Day 90

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
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
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

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=288 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
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 outcome

Timeframe: From Baseline up to Day 90

Population: The actual number of assessed patients was provided to each measure.

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=294 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Percent of Patients With Change in Clinical Global Impression Scale Very much improved	38.1 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale Much improved	46.9 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale Minimaly improved	11.2 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale No change	2.4 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale Minimaly worse	0.3 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale Much worse	0.3 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale Not assessed	0.7 percentage of participants

SECONDARY outcome

Timeframe: Up to 180 days

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=239 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
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
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 outcome

Timeframe: From Baseline up to Day 30

Population: The actual number of assessed patients was provided to each measure.

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. Improved	89.9 percentage of participants
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. Worsened	2.7 percentage of participants
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30. No change	7.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Gender Female	73.24 percentage of participants
Gender Male	26.76 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Race Asian	0.7 percentage of participants
Race White	99.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Family Status Civil marriage	1 percentage of participants
Family Status Divorced	5.4 percentage of participants
Family Status Married	65.9 percentage of participants
Family Status Single	15.7 percentage of participants
Family Status Widow(er)	12 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Education Elementary	3 percentage of participants
Education Secondary	33.8 percentage of participants
Education University	63.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=299 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Employment Employed	62.5 percentage of participants
Employment Unemployed	37.5 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 90, Up to 180 days

Population: The actual number of assessed patients was provided to each measure.

MoCA test used under license agreement www.mocatest.org

Scale range 0-30 Normal >=26 Higher values represent a better outcome

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) Baseline	25.2 units on a scale Standard Deviation 3.63
Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) Day 90	27 units on a scale Standard Deviation 2.69
Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA) Day 180	27.5 units on a scale Standard Deviation 2.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 90, Up to 180 days

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=296 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Insomnia Severity Index Baseline	13.4 units on a scale Standard Deviation 5.52
Insomnia Severity Index Day 90	6.6 units on a scale Standard Deviation 4.32
Insomnia Severity Index Day 180	4.5 units on a scale Standard Deviation 3.98

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline up to Day 90

Population: The actual number of assessed patients was provided to each measure.

Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90.

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=294 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 Improved	91.5 percentage of participants
Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 Worsened	4.1 percentage of participants
Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90 No change	4.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 90 up to Up to 180 days

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=239 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
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 outcome

Timeframe: From Day 90 up to 180 days

Population: The actual number of assessed patients was provided to each measure.

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

Outcome measures

Measure	Outpatients With Neurological Disorders and Depression. n=298 Participants Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
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
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 Much improved	29.3 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 Minimaly improved	9.6 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 No change	2.9 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 Minimaly worse	0.8 percentage of participants
Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180 Much worse	0.4 percentage of participants

Adverse Events

Outpatients With Neurological Disorders and Depression.

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Outpatients With Neurological Disorders and Depression. n=299 participants at risk Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.
Cardiac disorders Palpitations	0.67% 2/299 • Number of events 2 299 patients were in the Intent-to-treat population
Gastrointestinal disorders Abdominal pain	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Gastrointestinal disorders Diarrhea	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Gastrointestinal disorders Dry mouth	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Gastrointestinal disorders Nausea	1.3% 4/299 • Number of events 4 299 patients were in the Intent-to-treat population
General disorders Asthenia	1.7% 5/299 • Number of events 5 299 patients were in the Intent-to-treat population
General disorders Drug ineffective	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
General disorders Fatigue	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Nervous system disorders Coordination abnormal	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Nervous system disorders Dizziness	1.3% 4/299 • Number of events 4 299 patients were in the Intent-to-treat population
Nervous system disorders Headache	1.0% 3/299 • Number of events 3 299 patients were in the Intent-to-treat population
Nervous system disorders Hyperkinesia	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Nervous system disorders Postural tremor	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Nervous system disorders Somnolence	1.3% 4/299 • Number of events 4 299 patients were in the Intent-to-treat population
Nervous system disorders Tremor	0.67% 2/299 • Number of events 2 299 patients were in the Intent-to-treat population
Psychiatric disorders Agitation	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Psychiatric disorders Anxiety	1.3% 4/299 • Number of events 4 299 patients were in the Intent-to-treat population
Psychiatric disorders Insomnia	0.67% 2/299 • Number of events 2 299 patients were in the Intent-to-treat population
Psychiatric disorders Psychogenic tremor	0.67% 2/299 • Number of events 2 299 patients were in the Intent-to-treat population
Skin and subcutaneous tissue disorders Hyperhidrosis	0.33% 1/299 • Number of events 1 299 patients were in the Intent-to-treat population
Vascular disorders Hypotension	1.3% 4/299 • Number of events 4 299 patients were in the Intent-to-treat population

Additional Information

Tatiana V. Vladimirova

Abbott

Phone: +74952584280

Email: tatiana.vladimirova@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place