ow-dose ketamine infusion among adolescents with treatment-resistant depression: a randomized, double-blind placebo-control study.
Not Applicable
Recruiting
- Conditions
- treatment-resistant depression
- Registration Number
- JPRN-UMIN000046148
- Lead Sponsor
- Ministry of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer). (2)Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia. (3)Pregnancy. (4)Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine). (5)Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan) (6)Alcohol abuse / dependence within 6 months. (7)Attempt suicide in hospital. (8)Allergy to ketamine. (9)Abnormal liver function in recent 3 months. (10) Abnormal ECG (i.e.:arrhythmia). (11) Fever or infection in recent 5 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adolescents with treatment-resistant depression. 2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adolescents with treatment-resistant depression. 3. Changes in depressive symptoms measured by Children's Depression Rating Scale-Revised (CDRS-R) in adolescents with treatment-resistant depression. [Time Frame: clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28]
- Secondary Outcome Measures
Name Time Method