Clinical trial NCT02016261: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Depressive Disorder
Keywords: Cognitive function
Lead sponsor: Moscow Research Institute of Psychiatry
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2013-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)


Eligibility criteria: 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.

Primary outcomes:
measure: Change of time difference between Part I and Part II of Stroop Test
timeFrame: From baseline up to Week 24
Secondary outcomes:
measure: Change of total Frontal Assessment Battery score
timeFrame: From baseline up to Week 24
measure: Proportion of patients maintained remission status
timeFrame: Week 24
measure: Changes of Addenbrooke's Cognitive Examination general score
timeFrame: From baseline up to Week 24
measure: Change of The Social Adaptation Self-evaluation Scale total score
timeFrame: From baseline up to Week 24
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Research Institution of Psychiatry
Study officials:
affiliation: Moscow Research Institution of Psychiatry
name: Alexey E. Bobrov, Professor
role: PRINCIPAL_INVESTIGATOR
References: