The Sustained Effects of Ketamine

NCT02708849 | Terminated Phase 1 Results

• 1 other identifier: 1501015203
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to characterize the effects of a single, sub-anesthetic dose of ketamine in rs-fMRI in healthy subjects. Post-ketamine rs-fMRI data will demonstrate a pattern of increased global brain connectivity (GBC) in fronto-temporal cortex.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (2)

• Post-Ketamine Rs-fMRI Data

  24 hours post infusion fMRI data

  24 hours

• Global Brain Connectivity

  Participants will be randomized into one of two parallel groups-ketamine+lamotrigine or ketamine+placebo-and will complete pre- and post-ketamine rs-fMRI. The hypothesis is that post-ketamine rs-fMRI data will demonstrate a pattern of increased global brain connectivity (GBC) in fronto-temporal cortex. Insufficient number of participants for data collection.

  24 hours

Study Arms (2)

Ketamine plus lamotrigine

EXPERIMENTAL

Drug: Ketamine; Drug: Lamotrigine

ketamine plus placebo

PLACEBO COMPARATOR

Drug: Ketamine; Drug: Placebo

Interventions

Ketamine DRUG

The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion

Ketamine plus lamotrigine; ketamine plus placebo

Lamotrigine DRUG

lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine

Ketamine plus lamotrigine

Placebo DRUG

oral dose placebo

ketamine plus placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 21-65 years. Females will be included if they are not pregnant and agreed to utilize a barrier method contraceptive (e.g., condom or diaphragm with spermicide) tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
• Able to provide written informed consent according to Yale HIC guidelines.
• Agree to refrain from elective surgeries (including dental) for a 2-week period following study drug.
• Able to read and write English as a primary language.

You may not qualify if:

• Personal history of mood, anxiety, or psychotic axis I DSM-IV disorders confirmed after comprehensive psychiatric evaluation.
• Any history of serious medical or neurological illness.
• Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.
• A first-degree family member with history of schizophrenia.
• Lifetime history of psychoactive substance or alcohol dependence or substance or alcohol abuse (other than nicotine or caffeine abuse), or drinking more that 5 drinks/week during the last year.
• Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure (e.g. uncontrolled hypertension, hyperthyroidism, or hypothyroidism will be excluded).
• A positive pre-study (screening) urine drug screen or, at the study physician's discretion on any drug screens given before the scans.
• Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
• Positive HIV or Hepatitis B/C tests. This test will take place at the screening visit. Subjects will be invited back either for their next study visit or for a HIV/Hep debriefing session. A study clinician will inform them in person of the results. They will be given access to counselling and advised of the appropriate next steps.
• Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinion of the principal/co-investigator, the medication received will not interfere with the study procedures or compromise safety.
• Any history indicating learning disability, mental retardation, or attention deficit disorder.
• Known sensitivity to ketamine.
• Known sensitivity to lamotrigine.
• Body weight of 250 pounds or greater.
• History of claustrophobia.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Ketamine; Lamotrigine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chadi Abdallah
• Organization: Yale School of Medicine

chadi.abdallah@yale.edu

347-987-0717

Study Officials

• Chadi Abdallah, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 15, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Locations

US (1)