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

Information source: Moscow Research Institute of Psychiatry
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Depressive Disorder

Intervention: Fluvoxamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Moscow Research Institute of Psychiatry

Official(s) and/or principal investigator(s):
Alexey E. Bobrov, Professor, Principal Investigator, Affiliation: Moscow Research Institution of Psychiatry

Summary

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

Clinical Details

Official title: Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change of time difference between Part I and Part II of Stroop Test

Secondary outcome:

Change of total Frontal Assessment Battery score

Proportion of patients maintained remission status

Changes of Addenbrooke's Cognitive Examination general score

Change of The Social Adaptation Self-evaluation Scale total score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Moscow Research Institution of Psychiatry, Moscow 107076, Russian Federation
Additional Information

Starting date: December 2013
Last updated: July 20, 2015

Page last updated: August 23, 2015

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