Investigation of Antidepressant Efficacy of Oral Ketamine... | NCT02992496

Studies
Investigation of Antidepressant Efficacy of Oral Ketamine Treatment

NCT02992496

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Sep 3, 2019Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Major Depressive Episode

Interventions

Ketamine
Midazolam Hydrochloride

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2019

Last Update Posted Date

Sep 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketamine treatment group	Active Comparator	Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.	Drug: Ketamine
Control group	Active Comparator	Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks	Drug: Midazolam Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	1mg/kg, 6 applications over 2 weeks	Ketamine treatment group

Measure	Description	Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)		1 week

Measure	Description	Time Frame
Clinician Administered Dissociative States Scale (CADSS)		2 weeks
Hamilton Depression Rating Scale		1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
Hamilton depression rating scale score ≥ 19
Willingness and competence to sign the informed consent form
Stable psychopharmacological treatment for 10 days (except benzodiazepines)

Exclusion Criteria:

Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
Prior use of ketamine
Pregnancy/Breast feeding
Instable arterial hypertension >170/110mmHg
Hepatic dysfunction
Hyperthyreosis
History of glaucoma
Neurodegenerative disorders
Any unstable medical illness
History of substance abuse within the past 12 months
History of psychosis
Failure to comply with the study protocol or to follow the instructions of the investigating team
Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Psychotherapy, Medical University of Vienna	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic