Recurrent Depressive DisorderPhase 4NCT02016261
Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
A Phase 4 study testing Fluvoxamine in people with Recurrent Depressive Disorder, run by Moscow Research Institute of Psychiatry at 1 site in Russia.
Trial summary
Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Depressive Disorder
- What is being tested?
- Fluvoxamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent depressive disorder at least two years prior to enrollment into the study.
- At least two severe depressive episodes with or without psychotic symptoms in the past medical history.
- Stable patient in remission since at least 4 weeks after depressive episode and not more than 6 months after depressive episode.
- Planned prescription of fluvoxamine for preventive therapy in recurrent depressive disorder.
- The subject is fluent in Russian language.
- According to Stroop test one of following points has to be met - increase of the words reading time on 10% and more or three and more mistakes done.
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- Sum of Addenbrooke's Cognitive Examination total scores must be 93 or less.
- Male or female, between the ages of 18 and 65 years.
- If female, postmenopausal or birth control.
Who cannot join
- Diagnosis of the following concomitant psychiatric disorders: current depressive or maniac episode, bipolar affective disorder, persistent mood affective disorder (cyclothymia, dysthymia, other or unspecified persistent mood disorder), other or unspecified mood affective disorder, substance-related disorders, schizophrenia, or other psychotic disorders.
- History of a drug or alcohol disorder.
- Current treatment with fluvoxamine.
- History of depressive disorder associated with endocrine disorders.
- Pregnancy, breast-feeding female patients.
- History of any significant neurologic disease.
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- Treatment with electroconvulsive therapy in the 6 months preceding the study.
- Major risk of suicide.
- Hypersensitivity to fluvoxamine.
- Use of the medications, which are known to interact with fluvoxamine.
- Have initiated psychotherapy or other therapies (such as acupuncture or hypnosis).
- Have initiated cognitive remediation therapy within 12 weeks prior enrollment or at any time during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine
Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)
- Conditions
- Recurrent Depressive Disorder
- Being tested
- Fluvoxamine
- Keywords
- Cognitive function
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvoxamineDrug
Also called Fevarin®
The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg
| Study group | Role | What they receive |
|---|---|---|
| Remitted Depression Outpatients | Experimental | Adults 18-65 years old, males and females with the diagnosis of recurrent depressive disorder and who had at least two severe depressive episodes (with or without psychotic symptoms) of the disorder and who currently in remission Receives: Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time difference between Part I and Part II of Stroop Test
Measured: From baseline up to Week 24
Secondary outcomes (4)
Change of total Frontal Assessment Battery score
Measured: From baseline up to Week 24
Proportion of patients maintained remission status
Measured: Week 24
Changes of Addenbrooke's Cognitive Examination general score
Measured: From baseline up to Week 24
Change of The Social Adaptation Self-evaluation Scale total score
Measured: From baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Depressive DisorderStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Research Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Alexey E. Bobrov, Professor, Principal investigator, Moscow Research Institution of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016261
- Sponsor's protocol ID
- A13-996
- Status last verified
- Jul 2015
- First submitted
- 10 Dec 2013
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine
- ClinicalTrials.gov ID
- NCT02016261
- Acronym / sponsor ID
- A13-996
- Conditions
- Recurrent Depressive Disorder
- Keywords
- Cognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Moscow Research Institute of PsychiatryUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remitted Depression Outpatients | Experimental | Drug: FluvoxamineAdults 18-65 years old, males and females with the diagnosis of recurrent depressive disorder and who had at least two severe depressive episodes (with or without psychotic symptoms) of the disorder and who currently in remission |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of recurrent depressive disorder at least two years prior to enrollment into the study.
- At least two severe depressive episodes with or without psychotic symptoms in the past medical history.
- Stable patient in remission since at least 4 weeks after depressive episode and not more than 6 months after depressive episode.
- Planned prescription of fluvoxamine for preventive therapy in recurrent depressive disorder.
- The subject is fluent in Russian language.
Key exclusion criteria (12 listed)
- Diagnosis of the following concomitant psychiatric disorders: current depressive or maniac episode, bipolar affective disorder, persistent mood affective disorder (cyclothymia, dysthymia, other or unspecified persistent mood disorder), other or unspecified mood affective disorder, substance-related disorders, schizophrenia, or other psychotic disorders.
- History of a drug or alcohol disorder.
- Current treatment with fluvoxamine.
- History of depressive disorder associated with endocrine disorders.
- Pregnancy, breast-feeding female patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluvoxamineAlso: Fevarin®The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg | Drug | Remitted Depression Outpatients |
Primary outcome
Change of time difference between Part I and Part II of Stroop Test
Time frame: From baseline up to Week 24
4 secondary outcomes
Change of total Frontal Assessment Battery score
Time frame: From baseline up to Week 24
Proportion of patients maintained remission status
Time frame: Week 24
Changes of Addenbrooke's Cognitive Examination general score
Time frame: From baseline up to Week 24
Change of The Social Adaptation Self-evaluation Scale total score
Time frame: From baseline up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Alexey E. Bobrov, Professor principal investigator
Moscow Research Institution of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluvoxamine in people with Recurrent Depressive Disorder, run by Moscow Research Institute of Psychiatry at 1 site 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 9 inclusion and 12 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 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of time difference between Part I and Part II of Stroop Test (time frame: From baseline up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2015.