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

Recurrent Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016261
• Other study ID #: A13-996
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: July 20, 2015
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Moscow Research Institute of Psychiatry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Recurrent Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Moscow Research Institution of Psychiatry	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Moscow Research Institute of Psychiatry	Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of time difference between Part I and Part II of Stroop Test		From baseline up to Week 24	No
Secondary	Change of total Frontal Assessment Battery score		From baseline up to Week 24	No
Secondary	Proportion of patients maintained remission status		Week 24	No
Secondary	Changes of Addenbrooke's Cognitive Examination general score		From baseline up to Week 24	No
Secondary	Change of The Social Adaptation Self-evaluation Scale total score		From baseline up to Week 24	No