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

Phase 4

Completed

• Conditions: Recurrent Depressive Disorder
• Interventions: Drug: Fluvoxamine

• Registration Number: NCT02016261
• Lead Sponsor: Moscow Research Institute of Psychiatry

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remitted Depression Outpatients	Fluvoxamine	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

Primary Outcome Measures

Name	Time	Method
Change of time difference between Part I and Part II of Stroop Test	From baseline up to Week 24

Secondary Outcome Measures

Name	Time	Method
Change of total Frontal Assessment Battery score	From baseline up to Week 24
Proportion of patients maintained remission status	Week 24
Changes of Addenbrooke's Cognitive Examination general score	From baseline up to Week 24
Change of The Social Adaptation Self-evaluation Scale total score	From baseline up to Week 24

Trial Locations

Locations (1)

Moscow Research Institution of Psychiatry; 🇷🇺 Moscow, Russian Federation