NCT01551329

Brief Summary

The purpose of this study is to evaluate the efficacy of ketamine in reducing depressive symptoms in subjects with a comorbid major depressive episode and alcohol dependence. The investigators hypothesize the following for the present study: A single dose of ketamine will induce a rapid, robust and sustained reduction in depressive symptoms in subjects with a comorbid major depressive episode and alcohol dependence relative to placebo as defined by change in Hamilton Depression Rating Scale total scores at 72 hours post infusion. A single dose of ketamine can be delivered safely, with minimal adverse events or complications, in subjects with a comorbid major depressive episode and alcohol dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 depression

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

March 7, 2012

Last Update Submit

March 5, 2020

Conditions

DepressionAlcohol Dependence

Keywords

depressionalcoholcomorbidityketamineglutamateNMDA

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured using the Hamilton Depression Rating Scale

    29 Days

Study Arms (1)

Drug: Ketamine

EXPERIMENTAL
Drug: Ketalar (ketamine)

Interventions

Ketalar (ketamine)DRUG

Intravenous Ketamine 0.5mg/kg

Drug: Ketamine

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female (post-menopausal, surgically sterile or negative pregnancy test at screening and agreement to utilize a medically-approved birth control method including complete abstinence during the testing period) between the age of 21 and 65 years old.
  • Able to provide written informed consent according to the WHVA and Yale HIC guidelines.

You may not qualify if:

  • Current DSM-IV-TR major depressive episode (MDE) by structured clinical interview (SCID) and a MADRS score ¬\>20.
  • Current DSM-IV-TR alcohol dependence with one heavy drinking day (\> 4 standard drinks/session for men and \> 3 standard drinks/session for women) in the last 3 weeks.
  • Abstinent from drinking for \> 5 days prior to receiving ketamine.
  • No current psychotropic medications (excluding benzodiazepines during alcohol detoxification if needed) in last 2 weeks (4 weeks for fluoxetine).
  • Individuals who have completed a detoxification program and who are at least 5 days past their last drink.
  • Unstable medical condition or medical problem with known CNS effects, e.g. uncontrolled hypertension (SBP≥170 and/or DBP≥100) or confirmed history of alcohol-withdrawal seizures.
  • Active suicidal ideation, intent or plan.
  • Active DSM-IV-TR substance use disorder in past three months (other than an alcohol or nicotine use disorder).
  • Prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I d/o with psychotic features, MDD with psychotic features.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA CT Healthcare Systems

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

DepressionAlcoholism

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ismene Petrakis, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

US(1)