Back to resultsStudy to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
Primary Purpose
Recurrent Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Fluvoxamine
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Depressive Disorder focused on measuring Cognitive function
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Moscow Research Institution of Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remitted Depression Outpatients
Arm Description
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
Outcomes
Primary Outcome Measures
Change of time difference between Part I and Part II of Stroop Test
Secondary Outcome Measures
Change of total Frontal Assessment Battery score
Proportion of patients maintained remission status
Changes of Addenbrooke's Cognitive Examination general score
Change of The Social Adaptation Self-evaluation Scale total score
Full Information
NCT ID
NCT02016261
First Posted
December 10, 2013
Last Updated
July 20, 2015
Sponsor
Moscow Research Institute of Psychiatry
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT02016261
Brief Title
Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
Official Title
Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow Research Institute of Psychiatry
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Depressive Disorder
Keywords
Cognitive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remitted Depression Outpatients
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine
Other Intervention Name(s)
Fevarin®
Intervention Description
The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg
Primary Outcome Measure Information:
Title
Change of time difference between Part I and Part II of Stroop Test
Time Frame
From baseline up to Week 24
Secondary Outcome Measure Information:
Title
Change of total Frontal Assessment Battery score
Time Frame
From baseline up to Week 24
Title
Proportion of patients maintained remission status
Time Frame
Week 24
Title
Changes of Addenbrooke's Cognitive Examination general score
Time Frame
From baseline up to Week 24
Title
Change of The Social Adaptation Self-evaluation Scale total score
Time Frame
From baseline up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexey E. Bobrov, Professor
Organizational Affiliation
Moscow Research Institution of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Research Institution of Psychiatry
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
12. IPD Sharing Statement
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Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
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