Clinical trial NCT02880462: A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia
Official title: Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
sulforaphane
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2016-08-26
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.

This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

Detailed description: This study will be carried out in six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University.

Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

Eligibility criteria: Inclusion Criteria:

1. Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
2. First onset or duration of illness less than 3 years with current symptoms exacerbation
3. Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse)
4. Male and female with aged 18 to 50 years
5. PANSS total \>=75 at 2 weeks. .
6. Signed the study consent for participation

Exclusion Criteria:

1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
5. the routine blood tests showing abnormal renal, liver function or other metabolic results .
6. pregnant or lactating women

Primary outcomes:
measure: Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
timeFrame: 24 weeks
Secondary outcomes:
measure: side effects by SAFTEE
timeFrame: 24 weeks
measure: side effects by AIMS
timeFrame: 24 weeks
measure: side effects by BAS
timeFrame: 24 weeks
measure: side effects by SAS
timeFrame: 24 weeks
measure: Change of clinical symptoms by PANSS
timeFrame: 24 weeks
measure: Change of clinical symptoms of CGI
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Central South University
name: Jianjun Ou, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: Renrong Wu, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: Jingping Zhao, M.D Ph.D
role: STUDY_CHAIR
affiliation: University of California, San Diego
name: Hua Jin, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selley ML. Increased (E)-4-hydroxy-2-nonenal and asymmetric dimethylarginine concentrations and decreased nitric oxide concentrations in the plasma of patients with major depression. J Affect Disord. 2004 Jun;80(2-3):249-56. doi: 10.1016/S0165-0327(03)00135-6.
citation: Bitanihirwe BK, Woo TU. Oxidative stress in schizophrenia: an integrated approach. Neurosci Biobehav Rev. 2011 Jan;35(3):878-93. doi: 10.1016/j.neubiorev.2010.10.008. Epub 2010 Oct 23.