SchizophreniaPhase 2NCT01548612
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia
A Phase 2 study testing Sodium nitroprusside and Glucose solution in people with Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sodium nitroprusside and Glucose solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of schizophrenia
- Patients in an acute psychotic episode requiring full hospitalization
Who cannot join
- Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)
- Pregnancy
- Breastfeeding
- Previous hypersensitivity to sodium nitroprusside
- DSM-IV diagnosis of drug abuse or dependence
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University General Hospital of the Ribeirao Preto Medical School
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia
In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.
- Conditions
- Schizophrenia
- Being tested
- Sodium nitroprusside, Glucose solution
- Keywords
- Schizophrenia, Nitric oxide, Sodium nitroprusside
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium nitroprussideDrug
Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
Glucose solutionDrug
Intravenous infusion of glucose solution 5% for 240 minutes
| Study group | Role | What they receive |
|---|---|---|
| Sodium nitroprusside | Experimental | Not described Receives: Drug: Sodium nitroprusside |
| Placebo | Placebo comparator | Glucose solution 5% Receives: Drug: Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BPRS score
Brief Psychiatric Rating Scale
Measured: baseline and up to 4 weeks
Change in PANSS negative subscale score
Positive and Negative Syndrome Scale
Measured: Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks
Secondary outcomes (1)
Cognitive assessment
FAS, 2-back, Stroop Color Word Test
Measured: Baseline and after 12 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Eduardo Cecilio Hallak, University of Sao Paulo
- Investigators
- Jaime EC Hallak, Doctor, Principal investigator, Ribeirao Preto Medical School, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548612
- Sponsor's protocol ID
- SNPSCZ001
- Status last verified
- Mar 2012
- First submitted
- 13 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hallak JE, Maia-de-Oliveira JP, Abrao J, Evora PR, Zuardi AW, Crippa JA, Belmonte-de-Abreu P, Baker GB, Dursun SM. Rapid improvement of acute schizophrenia symptoms after intravenous sodium nitroprusside: a randomized, double-blind, placebo-controlled trial. JAMA Psychiatry. 2013 Jul;70(7):668-76. doi: 10.1001/jamapsychiatry.2013.1292.
PubMed 23699763
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01548612
- Acronym / sponsor ID
- SNPSCZ001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Nitric oxide, Sodium nitroprusside
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium nitroprusside | Experimental | Drug: Sodium nitroprusside |
| Placebo | Placebo comparator | Drug: Glucose solutionGlucose solution 5% |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of schizophrenia
- Patients in an acute psychotic episode requiring full hospitalization
Key exclusion criteria (5 listed)
- Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)
- Pregnancy
- Breastfeeding
- Previous hypersensitivity to sodium nitroprusside
- DSM-IV diagnosis of drug abuse or dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium nitroprussideIntravenous infusion of 0,5 mcg/kg/min for 240 minutes | Drug | Sodium nitroprusside |
| Glucose solutionIntravenous infusion of glucose solution 5% for 240 minutes | Drug | Placebo |
Primary outcome
Change in BPRS score
Time frame: baseline and up to 4 weeks
Brief Psychiatric Rating Scale
Change in PANSS negative subscale score
Time frame: Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks
Positive and Negative Syndrome Scale
1 secondary outcome
Cognitive assessment
Time frame: Baseline and after 12 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Derived from this study: PubMed 23699763Hallak JE, Maia-de-Oliveira JP, Abrao J, Evora PR, Zuardi AW, Crippa JA, Belmonte-de-Abreu P, Baker GB, Dursun SM. Rapid improvement of acute schizophrenia symptoms after intravenous sodium nitroprusside: a randomized, double-blind, placebo-controlled trial. JAMA Psychiatry. 2013 Jul;70(7):668-76. doi: 10.1001/jamapsychiatry.2013.1292.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime EC Hallak, Doctor principal investigator
Ribeirao Preto Medical School, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium nitroprusside and Glucose solution in people with Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BPRS score (time frame: baseline and up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.