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

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®)

Study Overview

• Status: Completed
• Conditions: Recurrent Depressive Disorder
• Intervention / Treatment: Drug: Fluvoxamine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 107076
    • Moscow Research Institution of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of time difference between Part I and Part II of Stroop Test	From baseline up to Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Moscow Research Institute of Psychiatry
• Collaborators: Abbott
• Investigators: Principal Investigator: Alexey E. Bobrov, Professor, Moscow Research Institution of Psychiatry

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Cognitive function
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluvoxamine
• Other Study ID Numbers: A13-996