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Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine

Sponsor
Moscow Research Institute of Psychiatry (Other)
Overall Status
Completed
CT.gov ID
NCT02016261
Collaborator
Abbott (Industry)
50
Enrollment
1
Location
1
Arm
19
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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®)

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Remitted Depression Outpatients

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

Drug: Fluvoxamine
The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg
Other Names:
  • Fevarin®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of time difference between Part I and Part II of Stroop Test [From baseline up to Week 24]

    Secondary Outcome Measures

    1. Change of total Frontal Assessment Battery score [From baseline up to Week 24]

    2. Proportion of patients maintained remission status [Week 24]

    3. Changes of Addenbrooke's Cognitive Examination general score [From baseline up to Week 24]

    4. Change of The Social Adaptation Self-evaluation Scale total score [From baseline up to Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Diagnosis of recurrent depressive disorder at least two years prior to enrollment into the study.

    2. At least two severe depressive episodes with or without psychotic symptoms in the past medical history.

    3. Stable patient in remission since at least 4 weeks after depressive episode and not more than 6 months after depressive episode.

    4. Planned prescription of fluvoxamine for preventive therapy in recurrent depressive disorder.

    5. The subject is fluent in Russian language.

    6. 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.

    7. Sum of Addenbrooke's Cognitive Examination total scores must be 93 or less.

    8. Male or female, between the ages of 18 and 65 years.

    9. If female, postmenopausal or birth control.

    Exclusion Criteria:

    1. 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.

    2. History of a drug or alcohol disorder.

    3. Current treatment with fluvoxamine.

    4. History of depressive disorder associated with endocrine disorders.

    5. Pregnancy, breast-feeding female patients.

    6. History of any significant neurologic disease.

    7. Treatment with electroconvulsive therapy in the 6 months preceding the study.

    8. Major risk of suicide.

    9. Hypersensitivity to fluvoxamine.

    10. Use of the medications, which are known to interact with fluvoxamine.

    11. Have initiated psychotherapy or other therapies (such as acupuncture or hypnosis).

    12. Have initiated cognitive remediation therapy within 12 weeks prior enrollment or at any time during the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moscow Research Institution of Psychiatry Moscow Russian Federation 107076

    Sponsors and Collaborators

    • Moscow Research Institute of Psychiatry
    • Abbott

    Investigators

    • Principal Investigator: Alexey E. Bobrov, Professor, Moscow Research Institution of Psychiatry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moscow Research Institute of Psychiatry
    ClinicalTrials.gov Identifier:
    NCT02016261
    Other Study ID Numbers:
    • A13-996
    First Posted:
    Dec 19, 2013
    Last Update Posted:
    Jul 21, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Moscow Research Institute of Psychiatry
    Cognitive function
    Additional relevant MeSH terms:
    Depressive Disorder
    Fluvoxamine

    Study Results

    No Results Posted as of Jul 21, 2015