Ketamine for Combined Depression and Alcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital of North Norway
About this trial
The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Currently abstinent from alcohol
At least moderate depression without psychotic features
Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20
Alcohol dependence
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine Hydrochloride
DrugFour single-doses, given two times per week for two weeks Dose: 0,8 mg/kg body weight Route of administration: intravenous infusions over 40 minutes
Midazolam Hydrochloride
DrugFour single-doses, given two times per week for two weeks Dose: 0,02 mg/kg body weight Route of administration: intravenous infusions over 40 minutes
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depression
Change from baseline using rater-blinded Montgomery-Åsberg Depression Rating Scale (MADRS) (range 0-60; higher score indicate worse outcome)
Time frame
Within 3 days after final treatment sessionSecondary outcomes
1
Alcohol craving tonic
Penn Alcohol Craving Scale (PACS) (range 0-30; higher score indicate worse outcome)
Time frame
Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session2
Alcohol craving phasic
Alcohol Craving Questionnaire - Short version (ACQ-short) (range 12-84; higher score indicate worse outcome)
Time frame
Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session3
Depression response/remission
Rates of response (50% or more reduction in MADRS from baseline) and remission (9 points or less in MADRS)
Time frame
Repeated measurements from baseline and 1 day, 1 week, 2 weeks and 4 weeks after final treatment session4
Relapse risk
Incidence of relapse in each group (defined as two or more consecutive heavy drinking days)
Time frame
From baseline until 6 months after baselineOther outcomes
1
Duration of antidepressant effect (blinded-rater assessed)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) (range 0-60; higher score indicate worse outcome)
Time frame
From baseline until 6 months after baseline2
Duration of antidepressant effect (self-report)
Change in the Beck Depression Inventory-II (BDI-II) (Range 0-63; higher score indicate worse outcome)
Time frame
From baseline until 6 months after baseline3
Tolerability using the ketamine side effect tool (KSET)
Physician-reported tolerability of each treatment session (good, moderate and poor)
Time frame
Up to 1 month4
Tolerability using the ketamine side effect tool (KSET)
Patient-reported tolerability of each treatment session (good, moderate and poor)
Time frame
Up to 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of North Norway
Lead sponsor
University of Exeter
Collaborator
Source ClinicalTrials.gov