Depression
Conditions
Interventions
Sponsors
University of Fukui, Research Center for Child Mental Development, Age2 Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have a clincal diagnosis of depression confirmed according to ICD-10 criteria. 2)Currently attending Fukui University hospital as an outpatient. 3) Must not be on medication, otherwise no oral intake of the following; antidepressants (fluoxetine, paroxetine, sertraline, escitalopram, milnacipran, duloxetine, mirtazapine), mood stabilizers (lithium, sodium valproate, carbamazepine, lamotrigine), atypical antipsychotic medication (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonaserin, paliperidone). 4) Subjects within the age range of 10 to 17 years old. 5) No changes in medication for at least 4 weeks prior to baseline visit. 6) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1)Subjects who have hypersensitivity towards tipepidine hibenzate. 2) Subjects who have not yet received informed consent of the current diagnosis. 3)Subjects who have any other current ICD-10 diagnosis of the following; "Organic, including symptomatic, mental disorders", "Mental and behavioural disorders due to psychoactive substance use", "Schizophrenia, schizotypal and delusional disorders", "Behavioural syndromes associated with physiological disturbances and physical factors", "Disorders of adult personality and behavior", "Mental Retardation", "Disorders of psychological development", "Behavioural and emotional disorders with onset usually occurring in childhood and adolescence". 4) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder. 5) Subjects who are receiving medication other than the above mentioned. 6) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy. 7) Subjects who have participated in other clinical studies 3 months prior to this study. 8) Subjects who are scheduled for an immediate therapeutic plan change due to unstable physical/psychological symptoms. 9) Subjects who have a history of suicide attempt within the past 1 year. 10) Subjects who, in the investigator's opinion, might not be suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression scale (SDS, Birelson) Clincal global impression | — |
Countries
Japan
Contacts
Public ContactAkemi Tomoda
University of Fukui, Research Center for Child Mental Development Age2 Division
Outcome results
None listed