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

NCT ID: NCT02016261

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fluvoxamine

Intervention Type: DRUG

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

Interventions

Fluvoxamine

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

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Moscow Research Institute of Psychiatry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexey E. Bobrov, Professor

Role: PRINCIPAL_INVESTIGATOR

Moscow Research Institution of Psychiatry

Locations

Moscow Research Institution of Psychiatry

Moscow, , Russia

Countries

Russia

Other Identifiers

A13-996

Identifier Type: -

Identifier Source: org_study_id