UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042201
Receipt number R000048169
Scientific Title Effects of single intravenous arketamine dose as adjunctive therapy for bipolar depression: a randomized, double-blind, crossover, placebo-controlled trial
Date of disclosure of the study information 2020/10/22
Last modified on 2023/11/01 04:59:39

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Basic information

Public title

Effects of single intravenous arketamine dose as adjunctive therapy for bipolar depression: a randomized, double-blind, crossover, placebo-controlled trial

Acronym

The ARKETP study

Scientific Title

Effects of single intravenous arketamine dose as adjunctive therapy for bipolar depression: a randomized, double-blind, crossover, placebo-controlled trial

Scientific Title:Acronym

The ARKETP study

Region

South America


Condition

Condition

Bipolar depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether arketamine produces rapid anti-depressive effects in patients with bipolar depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint will be a change in the overall MADRS score from day 1 (baseline) to day 2 (24 hours after the infusion).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A pilot study will be conducted with patients with bipolar depression at the doses of 0.5mg / kg and 1mg / kg. Afterwards, a randomized, double-blind, crossover, controlled study will be performed.
(R)-ketamine / placebo: patients will receive a single dose of (R)-ketamine or placebo, administered intravenously for 40 minutes. Afterwards, patients will receive another dose of the study drug cross-linked; that is, those who previously used (R)-ketamine will be switched to placebo, and those who receive placebo will be transferred to the active group. Pulse oximetry, heart rate, and blood pressure will be measured continuously from 15 minutes before each dose to 4 hours after each dose of arketamine or placebo to monitor safety. No patient will be released from the study protocol without all the measures necessary to ensure their safety being taken.

Interventions/Control_2

Placebo

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

RCT inclusion criteria: Both genders; age between 18 to 65 years; subjects must fulfill Diagnostic and Statistical Manual of Mental Disorders 5th Edition criteria for Depressive Episode of Bipolar Disorder types I and II, without psychotic features; age of disease onset before 40 years old; no current maniac episode; initial score of at least 25 on the Montgomery Asberg Depression Rating Scale at study baseline; subjects must, at some point in their past, have failed to respond to an adequate dose and duration of at least one antidepressant drug during a depressive episode; current depressive episode of at least 4 weeks duration; participants should take valproic acid or lithium at therapeutic doses (20mg / kg for valproic acid and 0.6-1.2 mEq / L for lithium) for at least 4 weeks prior to intervention.

Key exclusion criteria

RCT exclusion criteria: Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition; subjects with a history of substance abuse disorder, according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition, within the previous 3 months; female subjects who are either pregnant or breastfeeding; serious, unstable medical illnesses; history of seizures without a clear and resolved etiology; treatment with a monoamine oxidase inhibitors within the 4 weeks prior to study; treatment with any other concomitant medication that has been disallowed; presence of any medical illness likely to alter brain morphology and/or physiology; clinically significant abnormal laboratory tests; intellectual disabilities.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Lucas
Middle name C
Last name Quarantini

Organization

Federal University of Bahia

Division name

Laboratory of Neuropsychopharmacology

Zip code

40110060

Address

R. Dr. Augusto Viana, S/n - Canela

TEL

557132838076

Email

lcq@ufba.br


Public contact

Name of contact person

1st name Lucas
Middle name C
Last name Quarantini

Organization

Federal University of Bahia

Division name

Laboratory of Neuropsychopharmacology

Zip code

40110060

Address

R. Dr. Augusto Viana, S/n - Canela

TEL

557132838076

Homepage URL


Email

lcq@ufba.br


Sponsor or person

Institute

Federal University of Bahia

Institute

Department

Personal name



Funding Source

Organization

Fundacao de Amparo a Pesquisa do Estado da Bahia

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Professor Edgard Santos University Hospital

Address

R. Dr. Augusto Viana, S/n - Canela

Tel

557132838043

Email

cep.hupes@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

6

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 08 Month 20 Day

Date of IRB

2019 Year 06 Month 28 Day

Anticipated trial start date

2019 Year 08 Month 20 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 22 Day

Last modified on

2023 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name