Treatment-resistant monopolar/bipolar depression
Conditions
Interventions
Discontinuation of previous medication. Taking Lithium carbonate (400mg-1000mg, serum level >
=0.6mEq) . Repetitive (twice a week, 4 times total) administration of ketamine (0.5mg/kg/40min).
Discontinuation of previous medication. Placebo pills at night for duration of the study. Repetitive
Sponsors
Kurume University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants must fulfill ICD-10 criteria for F32 Major Depression, F33 Recurrent major depression, F31 Bipolar disorder 2.Participants who diagnosed F32 Major Depression, F33 Recurrent major depression have not responded to two or more adequate trials of an antidepressant (>=imipramine equivalent 150mg) for at least 4-6 weeks. Participants who diagnosed F31 Bipolar disorder have not responded to adequate trials of mood stabilizer or olanzapine or quetiapine. 3.Current Major Depressive Episode of at least moderate severity, defined as a HAM-D 17 score >=18. 4.Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
Exclusion criteria
Exclusion criteria: 1.Patients with any clinically significant psychiatric disorder other than ICD-10 criteria for F32, F33, F31. 2.Patients with Lifetime history of mood-incongruent psychotic features based on DSM-IV-TR. 3.Patients judged clinically to be at serious and imminent suicidal or homicidal risk. 4.Imminent risk of other harm. 5.Patients with any organic brain disease. 6.Patients with unstable medical illness. 7.Patients treated with lithium within two weeks of consent. 8.Patients who are intolerant to Ketamine or Lithium because of reasons below; thyroid dysfunction, parathyroid dysfunction, renal dysfunction, atrio-ventricular block, epilepsy, uncontrolled hypertension, adverse events in using ketamine or lithium ever before. 9.Women who are pregnant or who wish to become pregnant during the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depressive Scare Serum BDNF, Plasma HVA, MHPG Functional connectivity between dorsal nexus and precuneus using rfMRI. | — |
Countries
Japan
Contacts
Public ContactNaoki Horikawa
Kurume University School of Medicine Department of Neuropsychiatry
Outcome results
None listed