NCT01551329

CompletedPhase 1

Ketamine for Depression and Alcohol Dependence

Yale University Source

Yale University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

1111009339

Study Type

interventional

Actual enrollment (reported)

5

Locations

1 country

Sites

1

Timeline

Study Start

March 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2015

Actual (reported)

Study Completion

November 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 5 participants
Study completion date: November 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 7, 2012
Actual (reported)
First Posted
March 12, 2012
Actual (reported)
Primary Completion
November 2015
Actual (reported)
Study Completion
November 2015
Actual (reported)

Last Updated: March 9, 2020
Status Verified: March 2020
Last Update Submitted: March 5, 2020

Conditions

Alcohol Dependence Depression

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

VA Connecticut Healthcare System
US federal agencycollaborator
Yale University
Otherlead

Study Sites (1)

VA CT Healthcare Systems

West Haven, Connecticut, 06516, United States

MeSH Terms

Conditions

DepressionAlcoholism

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, Cyclic

Study Officials

Ismene Petrakis, M.D.
Yale University
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1Completed

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Fish Oil vs. Placebo on Subjective Effects of Alcohol

Phase 1Completed

NCT00851669

The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)

Phase 2Completed

NCT00719979

Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder

Phase 1Completed

NCT01209845

Ketamine for Low Mood States in the ER

Phase 1Completed

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.

Hydrocarbons

Organic Chemicals

Primary Completion

November 2015

Actual (reported)

Study Completion

November 2015

Actual (reported)

Last Updated

March 9, 2020

Record last verified: 2020-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01551329
Data provider: ClinicalTrials.gov
Source updated: 2020-03-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:09 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Drug: Ketamine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations