NCT02289248

Brief Summary

Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 depression

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

November 4, 2014

Last Update Submit

February 27, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Extinction Learning Task performance

    Hopkins Verbal Learning Test and extinction learning tasks will be administered both one week before and 24-hours after the first ketamine infusion and the change in scores compared.

    24 hours Post ketamine infusion

Secondary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    8 weeks

Study Arms (1)

Ketamine/CBT Group

EXPERIMENTAL

Subjects will undergo 2 week course of 4 intravenous infusions of ketamine (given twice weekly for two weeks) in combination with twice weekly cognitive behavioral therapy for a total of 8 weeks.

Drug: KetamineBehavioral: Cognitive Behavioral Therapy (CBT)

Interventions

KetamineDRUG

Subjects will undergo a twice weekly two week course of IV infusions of ketamine

Ketamine/CBT Group
Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Subjects will undergo twice weekly CBT for a total of 8 weeks

Ketamine/CBT Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suffering from a depressive episode (DSM 5; either Major Depressive Disorder or Bipolar Disorder) and having failed one or more standard antidepressant treatments during the current episode;
  • Age 18-65;
  • Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to study entry.

You may not qualify if:

  • Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening;
  • Active suicidal thoughts with a plan; current or recent (\<6 months ago) substance use disorder;
  • Non-affective psychosis (such as schizophrenia or schizoaffective disorder);
  • Pregnancy or breastfeeding;
  • Inability to speak English fluently;
  • A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results;
  • A history of CBT treatment in the past 12 months;
  • Dementia;
  • Delirium;
  • Any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in CBT.
  • Untreated hypertension as defined by a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements.
  • Recent myocardial infarction (within one year)
  • Syncopal event within the past year.
  • Congestive heart failure (CHF) New York Heart Association Criteria \>Stage 2
  • Angina pectoris.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Yale Psychiatric Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Depression

Interventions

KetamineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Samuel Wilkinson, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 13, 2014

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(2)