Is MS14 Helpful in Schizophrenia?
The Effect of MS14 in Association With Risperidone in Treatment of Schizophrenia: A Double Blind Randomized Control Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia patients or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Feb 2010
Shorter than P25 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMarch 9, 2010
February 1, 2010
8 months
March 8, 2010
March 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
after the completion of three months of therapy
Secondary Outcomes (1)
CGI and PANSS questionnaires as well as a questionnaire designed for drug induced side effects will be filled weekly
During the first six weeks of therapy, patients will be interviewed every week
Study Arms (2)
treatment group
ACTIVE COMPARATORThe treatment group receives Risperidone 2 mg per day in the beginning which is increased by 1 mg every day until reaching 4 mg/day; this regimen will be continued for three months. MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months.
Control group
PLACEBO COMPARATORReceives the same dosage of Risperidone. Placebo is given to this group in same form and appearance as MS14 in the other arm of the study.
Interventions
MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months
The treatment group receives Risperidone 2 mg per day in the beginning which is increased by 1 mg every day until reaching 4 mg/day; this regimen will be continued for three months.
Eligibility Criteria
You may qualify if:
- No other concurrent diseases
- Signing the consent form by either the patient or their guardian
- Proved diagnosis of schizophrenia through SCID structured interview
You may not qualify if:
- Patients with treatment resistance schizophrenia
- Recent resistance to risperidone
- Contraindications of MS14 or risperidone administration
- Patients with residual or simple schizophrenia
- Age over 65 or under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Farzan Institutelead
Study Sites (1)
Iran Psychiatric Training and Treatment Center
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seyed Vahid Shariat
Department of Psychiatry and Mental Health Research Center, Iran University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 9, 2010
Study Start
February 1, 2010
Primary Completion
October 1, 2010
Study Completion
April 1, 2011
Last Updated
March 9, 2010
Record last verified: 2010-02