NCT01627782

Brief Summary

The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 major-depressive-disorder

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

13 active sites

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

First Submitted

Initial submission to the registry

June 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 6, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2013

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 5, 2016

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

June 22, 2012

Results QC Date

May 10, 2016

Last Update Submit

April 25, 2025

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderTreatment-resistant depressionKetamine

Outcome Measures

Primary Outcomes (1)

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

    Baseline (Day 1) and Day 15

Secondary Outcomes (15)

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29

    Baseline (Day 1) and Day 29

  • Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Day 15 and Day 29

  • Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Day 15 and Day 29

  • Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Day 15

  • Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)

    Baseline (Day 1) and Endpoint (Day 29)

  • +10 more secondary outcomes

Study Arms (4)

Placebo 3 times/week

PLACEBO COMPARATOR
Drug: Placebo

Ketamine 3 times/week

EXPERIMENTAL
Drug: Ketamine

Ketamine 2 times/week

EXPERIMENTAL
Drug: Ketamine

Placebo 2 times/week

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.

Placebo 2 times/weekPlacebo 3 times/week
KetamineDRUG

Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.

Ketamine 2 times/weekKetamine 3 times/week

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be medically stable on the basis of clinical laboratory tests performed at screening
  • Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features
  • Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant
  • Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score \>= 40 at screening and predose at Day 1
  • Inpatient or agreed to be admitted to the clinic on each dosing day

You may not qualify if:

  • Has uncontrolled hypertension
  • Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
  • Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients
  • Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Centennial, Colorado, United States

Location

Unknown Facility

Hartford, Connecticut, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Marlton, New Jersey, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Related Publications (2)

  • Lewis S, Romano C, De Bruecker G, Murrough JW, Shelton R, Singh JB, Jamieson C. Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression. Patient. 2019 Oct;12(5):527-537. doi: 10.1007/s40271-019-00369-8.

    PMID: 31270774DERIVED

  • Johnson KM, Devine JM, Ho KF, Howard KA, Saretsky TL, Jamieson CA. Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response. J Clin Psychiatry. 2016 Dec;77(12):1681-1686. doi: 10.4088/JCP.15m10253.

    PMID: 28086004DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Senior Director, Clinical Research
Organization
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 26, 2012

Study Start

August 6, 2012

Primary Completion

September 12, 2013

Study Completion

September 12, 2013

Last Updated

April 29, 2025

Results First Posted

August 5, 2016

Record last verified: 2025-04

Locations

US(13)