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

Moscow Research Institute of Psychiatry

Status and phase: Completed; Phase 4

Conditions: Recurrent Depressive Disorder

Treatments: Drug: Fluvoxamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02016261

A13-996

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Remitted Depression Outpatients

Experimental group

Description:

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

Treatment:

Drug: Fluvoxamine