Major depressive disorder
Conditions
Interventions
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
Sponsors
Department of Neuropsychiatry, The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with current DSM-IV Major Depressive Disorder single episode or recurrent. 2) Patients who understand the study contents and give informed consents by themselves
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationship between changes of neurophysiological indicators (Near-infrared spectroscopy) and clinical indicator (HAM-D). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed