UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033473 |
|---|---|
| Receipt number | R000038170 |
| Scientific Title | Efficacy of sodium nitroprusside in the treatment of drug-naive subjects in first episode psychosis - an open label study |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2019/07/05 21:19:08 |
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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
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
marceloadelino221@gmail.com
Sponsor or person
Institute
Sinapse Bairral Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038170
