DepressionFRIENDSNCT02043197

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

An observational study of Depression, run by Abbott at 29 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
How many people: 300 participants
Where: 29 sitesRussia
Study dates: Jan 2014to Nov 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinics

Who may be able to join

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.

Who cannot join

Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Russia29 sites

Research Facility ID ORG-000890
Chelyabinsk, 454080
Research facility ID ORG-000881
Krasnoyarsk, 660037
Research facility ID ORG-000893
Moscow, 117342
Research facility ID ORG-000882
Moscow, 119435
Research facility ID ORG-000876
Moscow, 127644
Research facility ID ORG-000877
Moscow, 129110
Research Facility ID ORG-000889
Nizhny Novgorod, 603006
Research facility ID ORG-000880
Novosibirsk, 630991
Research Facility ID ORG-000879
Penza, 440034
Research facility ID ORG-000891
Perm, 614000
Research facility ID ORG-000840
Perm, 614010
Research facility ID ORG-000803
Rostov-on-Don, 344000
Research facility ID ORG-000898
Rostov-on-Don, 344010
Research facility ID ORG-001028
Rostov-on-Don, 344010
Research facility ID ORG-001027
Rostov-on-Don, 344011
Research facility ID ORG-000894
Rostov-on-Don, 344015
Research facility ID ORG-000896
Saint Petersburg, 193312
Research facility ID ORG-000892
Saint Petersburg, 194044
Research facility ID ORG-000965
Saint Petersburg, 197022
Research facility ID ORG-000897
Samara, 443110
Research facility ID ORG-000839
Saratov, 410012
Research Facility ID ORG-000873
Spassk-Dal'niy, 692237
Research Facility ID ORG-000878
Tver', 170036
Research facility ID ORG-001026
Vladivostok, 690024
Research Facility ID ORG-000874
Volgograd, 400007
Research Facility ID ORG-000888
Volgograd, 400009
Research Facility ID ORG-000895
Voronezh, 394066
Research facilility ID ORG-000872
Yekaterinburg, 620141
Research facility ID ORG-000875
Yessentuki, 357601

Other trials in Russia

About this study

Official title: Post-Marketing Observational Program of Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)

Conditions: Depression
Keywords: Depression,, depressive symptoms,, major depressive disorder,, Fevarine,, fluvoxamine,, cognitive function,, neurological disorders,, sleep state
Medical subject headings: Depression, Depressive Disorder, Major, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02043197
Study group	Role	What they receive
Outpatients with neurological disorders and depression.		Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline

Secondary outcomes (12)

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
Measured: From Baseline up to Day 30 and Day 90
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30
Measured: From Baseline up to Day 30
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
Measured: From Baseline up to Day 30 and Day 90
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
Measured: Baseline, Day 90
Percent of Patients With Change in Clinical Global Impression Scale
Measured: From Baseline up to Day 90
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
Measured: Up to 180 days
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.
Measured: From Baseline up to Day 30
Gender
Measured: Baseline
Race
Measured: Baseline
Family Status
Measured: Baseline
Education
Measured: Baseline
Employment
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2015

First posted23 Jan 2014 (estimated)
Study startJan 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02043197
Sponsor's protocol ID: P14-326
Acronym: FRIENDS
Status last verified: Jun 2018
First submitted: 23 Dec 2013
Last updated: 17 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Observational Program of Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorders (FRIENDS)
ClinicalTrials.gov ID: NCT02043197
Acronym / sponsor ID: FRIENDS / P14-326
Conditions: Depression
Keywords: Depression,, depressive symptoms,, major depressive disorder,, Fevarine,, fluvoxamine,, cognitive function,, neurological disorders,, sleep state
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Manipal Acunova Ltd.
Study start: Jan 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Posted 17 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Outpatients with neurological disorders and depression.	–	–Outpatients with mild or moderate symptoms of depression prescribed by Fevarin® in accordance with the approved local label.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinics

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).
Time frame: 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.

12 secondary outcomes

Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Time frame: From Baseline up to Day 30 and Day 90
Percent of Patients With Change of Depression Symptoms From Baseline to Day 30
Time frame: From Baseline up to Day 30
Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Time frame: From Baseline up to Day 30 and Day 90
Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale
Time frame: Baseline, Day 90
Percent of Patients With Change in Clinical Global Impression Scale
Time frame: From Baseline up to Day 90
Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 180 days
Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.
Time frame: From Baseline up to Day 30
Gender
Time frame: Baseline
Race
Time frame: Baseline
Family Status
Time frame: Baseline
Education
Time frame: Baseline
Employment
Time frame: Baseline

Results and safety

Results posted to the registry on 17 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Outpatients With Neurological Disorders and Depression.	300	292

Primary outcome: Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).

Time frame: Baseline. Number (95% Confidence Interval). Unit: Percentage

Measure	Outpatients With Neurological Disorders and Depression. n = 299
International Classification of Diseases G00-G99	49.2 (43.4 to 55)
International Classification of Diseases I00-I99	31.8 (26.5 to 37.4)
International Classification of Diseases M00-M99	20.1 (15.7 to 25.1)
International Classification of Diseases T00-T99	2.7 (1.2 to 5.2)

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

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Outpatients With Neurological Disorders and Depression.	0 of 299 (0%)	22 of 299 (7.4%)	0 of 299

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tatiana Vladimirova, MD, PhD study director

Abbott

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by Abbott at 29 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®). (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.