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Completed

NCT Number: NCT02016261

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moscow Research Institution of Psychiatry

Moscow, 107076, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fluvoxamine

Drug

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

Other names: Fevarin®

Primary outcomes

  1. Change of time difference between Part I and Part II of Stroop Test

    Time frame: From baseline up to Week 24

Secondary outcomes

  1. Change of total Frontal Assessment Battery score

    Time frame: From baseline up to Week 24

  2. Proportion of patients maintained remission status

    Time frame: Week 24

  3. Changes of Addenbrooke's Cognitive Examination general score

    Time frame: From baseline up to Week 24

  4. Change of The Social Adaptation Self-evaluation Scale total score

    Time frame: From baseline up to Week 24

Sponsors and collaborators

Lead sponsor

Moscow Research Institute of Psychiatry

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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