Major Depressive Disorder Clinical Trial
Official title:
Open-Label Intravenous Subanesthetic Ketamine for Adolescents With Treatment-Resistant Depression
NCT number | NCT02078817 |
Other study ID # | 22225 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | March 2018 |
Verified date | January 2020 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the use of ketamine for treatment of depression in adolescents that have not responded to other treatments. We will also examine neurobiological mechanisms of treatment.
Status | Completed |
Enrollment | 14 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Male and female adolescents aged 12 to 18 years. - Presence of recurrent major depression without psychotic features confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia - Parent and Lifetime Version (Kaufman et al., 1997). - Current depression severity measured by the Children's Depression Rating Scale (CDRS) (Poznanski, 1985) raw score greater than or equal to 36 at screening and the day ketamine is due to be received for the first time. - Current depressive episode resistant to treatment, defined as failure to achieve remission (elimination of symptoms and restoration of pre-morbid psychosocial functioning) from at least 2 antidepressant trials of different pharmacological classes. Systematic evaluation of previous antidepressant trials will be assessed by using the Antidepressant Treatment History Form (Sackeim, 2001). - If present, current antidepressant medication treatment must be dose stable for at least 2 months prior to beginning the study. (Patients will continue with current antidepressant treatment throughout the study. Based on our experience in current research at the VA Medical Center using serial ketamine for adult TRD, patients have shown positive results while continuing their current antidepressant treatment.) Exclusion Criteria: - Inability to speak English - Inability or unwillingness to provide written informed consent - A history of Mental Retardation or any Pervasive Developmental Disorder - Current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified. - Family history with a first degree relative with schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified. - Diagnosis of seizures or other neurological disorders. - Comorbid diagnosis of substance abuse or dependence, current or past. - Clinically unstable medical illness. - Current use of the following medications: any barbiturates, any narcotics, any non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for insomnia. - For women: pregnancy (confirmed by baseline lab test). - The presence of any MRI contra-indications such as MRI-incompatible metals in the body or claustrophobia. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Responders Measured by Clinical Global Impression (CGI) | Responders will be defined as those with CGI ratings (given by the study clinician) of 1 or 2 (much or very much improved). Patients that are given a scores of 3-7 (minimally improved to very much worse) will be considered non-responders. | 2 weeks | |
Secondary | Children's Depression Rating Scale-Revised | The CDRS-R measure is given in interview form to child and parent separately. A consensus is then created with best-estimate for 17 items (each with a range of 1-5 or 1-7) using both sources of information. The total score is the sum of 17 item scores, ranging from 17-113 with higher scores indicating greater depression symptoms. | 2 weeks | |
Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) | MADRS is a 10-item clinician-administered inventory measuring depression symptoms. Items are scored on a scare from 0 (none) to 6 (constant). Total scores are a sum of the 10 item scores, ranging from 0 to 60, with higher scores indicating greater symptom severity. | 2 weeks | |
Secondary | Beck Depression Inventory-II (BDI-II) | BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms. | 2 weeks | |
Secondary | Change in Clinician Administered Dissociative States Scale (CADSS) | CADSS is a 27-item instrument measuring symptoms of dissociative stress, with 19 items completed by the patient and 8 items completed by the clinician. Items are rated on a scale of 0 (not at all) to 4 (extreme). Total scores are a sum of the 27 item scores and range from 0 to 108, with higher scores indicating greater symptom severity. | baseline, 2 weeks | |
Secondary | Maximum Change in Systolic Blood Pressure | Vital signs were measured every 15 minutes, starting from the beginning of the infusion and ending 2 hours after the infusion ended (2 hours, 40 minutes total). Maximum increase of blood pressure compared to baseline was calculated. | 2 hours and 40 minutes | |
Secondary | Maximum Change in Diastolic Blood Pressure | baseline, 45 minutes post infusion | ||
Secondary | Maximum Change in Heart Rate | 4 hours | ||
Secondary | Maximum Decrease in Pulse Oximetry | 4 hours |
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