UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of sodium nitroprusside in the treatment of drug-naive subjects in first episode psychosis - an open label study
Acronym	Efficacy of sodium nitroprusside in the treatment of drug-naive subjects in first episode psychosis - an open label study
Scientific Title	Efficacy of sodium nitroprusside in the treatment of drug-naive subjects in first episode psychosis - an open label study
Scientific Title:Acronym	Efficacy of sodium nitroprusside in the treatment of drug-naive subjects in first episode psychosis - an open label study
Region	South America

Condition
Condition	Regarding the design, this will be an open, non-randomized study.
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of sodium nitroprusside administered as a single dose in the treatment of subjects in the first psychotic episode with no history of prior antipsychotic treatment To assess the tolerability of sodium nitroprusside administered as a single dose in subjects in the first psychotic episode with no history of prior antipsychotic treatmen
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of positive symptoms using the PANSS scale. Before the procedure and after 24 hours
Key secondary outcomes	Evaluation of negative symptoms, mania and general psychopathology, as well as side effects and tolerance. Using the PANSS and EACA-M scales.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A single infusion session will be performed in which sodium nitroprusside will be used in continuous intravenous infusion under strict monitoring at a dose of 0.5 ug / kg / min for 240 minutes (04 hours). For administration, an infusion pump will be used and the medicament will be prepared and administered by a skilled practitioner in its use.
Interventions/Control_2
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients of both sexes, With first psychotic episode without previous treatment with antipsychotic. Age between 18 and 60 years
Key exclusion criteria	Presence of relevant medical condition (cardiovascular diseases, neurological diseases, renal failure, liver disease, hypothyroidism, hyponatremia, hypovitaminosis B12, pregnancy, breastfeeding) or established and diagnosed organic frameworks. History of hypersensitivity to sodium nitroprusside. Diagnosis of substance abuse or dependence according to DSM-IV-TR criteria.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Marcelo Middle name Pinheiro Machado Last name Adelino
Organization	Institute Bairral of Psychiatry
Division name	Sinapse Bairral Research Center
Zip code	13970905
Address	Hortencio Pereira da Silva 313 Itapira Brazil
TEL	551938639400
Email	marceloadelino221@gmail.com

Public contact
Name of contact person	1st name Marcelo Middle name Pinheiro Machado Last name Adelino
Organization	Institute Bairral of Psychiatry
Division name	Sinapse Bairral Research Center
Zip code	13970905
Address	Hortencio Pereira da Silva 313 Itapira Brazil
TEL	551938639400
Homepage URL
Email	marceloadelino221@gmail.com

Sponsor
Institute	Sinapse Bairral Research Center
Institute
Department

Funding Source
Organization	Sinapse Bairral Research Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Brazilian

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sinapse Bairral Research Center
Address	Hortencio Pereira da Silva 313 Itapira Brazil
Tel	551938639400
Email	marceloadelino221@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	Institute Bairral of Psychiatry

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry	2019 Year 02 Month 01 Day
Date trial data considered complete	2019 Year 02 Month 01 Day
Date analysis concluded	2019 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 23 Day
Last modified on	2019 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038170