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

NCT02016261 | Completed Phase 4

• 1 other identifier: A13-996
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Depressive Disorder

Keywords

Cognitive function

Outcome Measures

Primary Outcomes (1)

• Change of time difference between Part I and Part II of Stroop Test

  From baseline up to Week 24

Secondary Outcomes (4)

• 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

Study Arms (1)

Remitted Depression Outpatients

EXPERIMENTAL

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

Interventions

Fluvoxamine DRUG

The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg

Also known as: Fevarin®

Remitted Depression Outpatients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moscow Research Institute of Psychiatry: lead
• Abbott: collaborator

Study Sites (1)

Moscow Research Institution of Psychiatry

Moscow, 107076, Russia

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Officials

• Alexey E. Bobrov, Professor

  Moscow Research Institution of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

RU (1)