Depression Clinical Trial
— KINDREDOfficial title:
Ketamine for Relapse Prevention in Recurrent Depressive Disorder: a Randomised, Controlled, Pilot Trial: the KINDRED Trial
Verified date | January 2020 |
Source | St Patrick's Hospital, Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for depression relapse prevention in persons at high risk. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
Status | Terminated |
Enrollment | 9 |
Est. completion date | May 23, 2018 |
Est. primary completion date | May 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - =18 years old - Hamilton Rating Scale for Depression, 24-item (HRSD-24) score of =21 - Voluntary admission for treatment of acute depressive episode - Meet DSM-IV criteria for recurrent depressive disorder (RDD): =2 previous depressive episodes with at least 2-months(consecutive) subthreshold or no symptoms in between PLUS(to enrich the sample for those at high risk for relapse) must also have experienced =3 major depressive episodes(including index episode) within the previous 2 years For the randomised pilot trial, RDD patients must have: - received antidepressant treatment for the acute depressive episode(pharmacological, psychotherapeutic or multidisciplinary) - =60% decrease from baseline HRSD-24 score and score =16 - Standardised Mini-Mental State Examination (sMMSE) score of =24 - able to provide informed consent Exclusion Criteria: - Current involuntary admission - Medical condition rendering unfit for ketamine/midazolam - Active suicidal intention - Dementia - History of Axis 1 diagnosis other than RDD - Electroconvulsive therapy (ECT) for treatment of current depressive episode - Alcohol/substance abuse in previous six months - Pregnancy or inability to confirm use of adequate contraception during the trial |
Country | Name | City | State |
---|---|---|---|
Ireland | St Patrick's University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
St Patrick's Hospital, Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion Rate for Randomised Treatment Phase | The outcomes for this pilot trial are process outcomes, primarily rates of recruitment and retention. Thus, the completion rate for the randomised treatment phase is the primary outcome. The study is not designed to assess efficacy. | 2 years | |
Secondary | Depression Relapse Rate During Treatment and Follow-up Phase | Clinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) was used to assess for the main clinical outcome, the relapse rate over six months. Criteria for relapse are =10 point increase in HRSD-24 compared to baseline score plus HRSD =16; in addition, increase in the HRSD should be maintained one week later (if indicated, additional follow-ups will be arranged). Hospital admission, and deliberate self-harm/suicide also constitute relapse. Relapse may also occur during the eight-week treatment phase and is captured here. | 8 months |
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