Shortened LSD Intervention for Major Depressive Disorder
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorJohns Hopkins University
About this trial
The purpose of this study is to determine the safety and clinical effectiveness of a shortened lysergic acid diethylamide (LSD) experience. This will be achieved by administering the drug risperidone 45-minutes after the administration of LSD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have given written informed consent
Meet DSM-5 criteria for MDD
MADRS >= 28 at screening Can read, write, and speak English fluently
Be judged by study team clinicians to be at low risk for suicidality
Disqualifiers
Women who are pregnant, nursing, or not practicing an effective means of birth control
Cardiovascular conditions: hypertension with resting blood pressure systolic >139 or diastolic >89, angina, heart rate > 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc > 450), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy
Epilepsy
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Trial design
Design model
Single group
Treatments tested in this trial
LSD
DrugParticipants will be administered LSD followed 45-minutes later by risperidone.
Risperidone
DrugParticipants will be administered LSD followed 45-minutes later by risperidone.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: LSD + RisperidoneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Score range from 0 to 60. Higher scores indicate worse depression symptoms
Time frame
1 monthSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: