An exploratory study for development of neurophysiological indicators for prediction and evaluation of effectiveness of serotonin reuptake inhibitor fluvoxamine in patients with major depressive disorder

UMIN ID: UMIN000001297

Registered date:04/08/2008

Basic Information

• Health condition(s) or Problem(s) studied: Major depressive disorder
• Date of first enrollment: 2008/08/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

12-week fluvoxiamine therapy
Continuation of 36-week fluvoxamine therapy in the patient group that satisfies HAM-D response criteria by 12-week fluvoxamine therapy

Outcome(s)

• Primary Outcome: Relationship between changes of neurophysiological indicators (Near-infrared spectroscopy) and clinical indicator (HAM-D).
• Secondary Outcome: 1.Numbers that satisfies HAM-D response criteria. 2.Numbers that satisfies HAM-D remission criteria. 3.Numbers that satisfies HAM-D recovery criteria. 4.CES-D, GAF, SASS, QOL-26, CGI 5. gene polymorphisms of sigma-1 receptor 6. BDNF blood concentration

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) No major cognitive deficits 2) Subjects taking fluvoxamine therapy 3) Subjects who cannot discontinue therapies listed below from 7 days prior to the trial start to the end point. 1. Thioridazine Hydrochloride, pimozide 2. Tizanidine hydrochloride 3. MAO inhibitors, Selegiline hydrochloride ( 14 days before starting the trial) 4. Cisapride 5. Any drugs under development 6. Any anticonvulsants 7. Any antipsychotic drugs 8. Antidepressants excluding Fluvoxamine 9. Lithium Carbonate 10. Chinese medicine effective on psychotic symptoms 11. Electroconvulsive therapy 12. Other physical treatments 4) Subjects with current DSM-IV personality disorder or mental retardation 5) Pregnant or lactating women 6) Subjects with severe hepatic dysfunction (AST>100 or ALT>100) 7) Subjects with severe renal dysfunction (BUN>25 or Cre>2.0) 8) Subjects with current or past history of convulsion 9) Subjects with current or past history of serious suicidal ideation or attempt (HAM-D item No.11 score > 3) 10) Subjects with past history of manic state or bipolar disorder 11) Subjects with brain organic disease, including current or past history of cerebrovascular disease and other related disorders 12) Past history of electric convulsive therapy 13) Subjects with cardiac failure which requires clinical treatment 14) Subjects with hemophilic disease or hemophilic factor which requires clinical treatment 15) Subjects with thyroidal dysfunction which requires clinical treatment 16) Ungiven notification of the disease name 17) Patient whom examination doctor judged improper as a trial subject

Related Information

• Primary Sponsor: Department of Neuropsychiatry, The University of Tokyo Hospital
• Source(s) of Monetary Support: Health, Labour and Welfare Ministry