SchizophreniaPhase 2NCT01083381
Is MS14 Helpful in Schizophrenia?
A Phase 2 study testing MS14 and Risperidone in people with Schizophrenia, run by Farzan Institute at 1 site in Iran.
Trial summary
In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia patients or not. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MS14 and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to Apr 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No other concurrent diseases
- Signing the consent form by either the patient or their guardian
- Proved diagnosis of schizophrenia through SCID structured interview
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Iran Psychiatric Training and Treatment Center
Tehran, Tehran Province
About this study
Official title: The Effect of MS14 in Association With Risperidone in Treatment of Schizophrenia: A Double Blind Randomized Control Trial
In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia patients or not.
Read the detailed description
Schizophrenia is a chronic illness characterized by disturbances in cognition, affect and behavior, all of which have a bizarre aspect. It is a common disorder, with a prevalence of about 1%. It has an equal prevalence in both sexes although men manifest their symptoms earlier than women. [1, 2] Individuals with schizophrenia have a 2-3 fold increase in mortality rate compared to the general population. This rate had increased in recent decades. [3, 4] Most patients are incapable of maintaining their jobs and relationships. About half attempt suicide, and about 10% succeed. Most suicides occur early in the course of the illness. [1] Optimal management of schizophrenia requires psychological, social, and occupational therapies. [2] There are a lot of antipsychotic drugs which are necessary for treatment. Risperidone, an atypical antipsychotic, has been approved by the Food and Drug Administration for the treatment of schizophrenia in the adolescent population in the adolescent population. [5] Although atypical antipsychotic agents have improved outcomes in schizophrenia, their clinical potential remains limited by patients' nonadherence to medication. [6] Some of the patients with schizophrenia do not respond completely to treatment and only experience a partial improvement and remain functionally impaired. While medication has been found to be effective for the treatment of "positive" symptoms of the disease, treatment of the "negative symptoms" of schizophrenia (including lack of energy, motivation, and emotions) has historically not been very successful. [4, 5] MS14 is an Iranian herbal-marine compound that has been patented by invention and patent registration office of Islamic Republic of Iran (no: 29350) and classified as equivalent to food with no observable adverse effect level (NOAEL). [8, 9] According to analytic data this compound contains many inorganic salts or complexes and also trace elements such as bromine (Br), strontium (Sr), vanadium (V), titanium (Ti), nickel (Ni) and zinc (Zn). [10] Safety of MS14 has been confirmed by sub-acute toxicity studies in rats (clinical, histopathological, hematological and biochemical). [8] A study of MS14 in experimental allergic encephalomyelitis (EAE) model has shown that oral treatment of the EAE mice with MS14 not only halts the progression of the disease but also attenuates the inflammation in CNS indicating that this herbal-marine compound has anti-inflammatory effects [11].
Overall, alleviation of clinical and neurological symptoms in EAE mice by MS14 explained the beneficial effects of traditionally used MS14 in MS patients, an effect which could also be investigated in other groups of psychological and neurological diseases. Additionally, there are anecdotal but unconfirmed reports for the effectiveness of MS14 in patients with schizophrenia. In this regard, we have decided to perform a randomized placebo-controlled study on the effect of MS14 on schizophrenia, to assess the safety and efficacy of this compound.
- Conditions
- Schizophrenia
- Being tested
- MS14, Risperidone
- Keywords
- Schizophrenia treatment MS14 randomized clinical trial
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS14Drug
MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months
RisperidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | 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. MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months. Receives: Drug: MS14; Drug: Risperidone |
| Control group | Placebo comparator | Receives 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. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 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
Measured: During the first six weeks of therapy, patients will be interviewed every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farzan Institute
- Sponsor type
- University, hospital or other
- Investigators
- Seyed Vahid Shariat, Principal investigator, Department of Psychiatry and Mental Health Research Center, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083381
- Sponsor's protocol ID
- 09123272376
- Status last verified
- Feb 2010
- First submitted
- 8 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of MS14 in Association With Risperidone in Treatment of Schizophrenia: A Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01083381
- Acronym / sponsor ID
- 09123272376
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia treatment MS14 randomized clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Farzan InstituteUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 9 Mar 2010 (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 this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia patients or not.
Detailed description
Schizophrenia is a chronic illness characterized by disturbances in cognition, affect and behavior, all of which have a bizarre aspect. It is a common disorder, with a prevalence of about 1%. It has an equal prevalence in both sexes although men manifest their symptoms earlier than women. [1, 2] Individuals with schizophrenia have a 2-3 fold increase in mortality rate compared to the general population. This rate had increased in recent decades. [3, 4] Most patients are incapable of maintaining their jobs and relationships. About half attempt suicide, and about 10% succeed. Most suicides occur early in the course of the illness. [1] Optimal management of schizophrenia requires psychological, social, and occupational therapies. [2] There are a lot of antipsychotic drugs which are necessary for treatment. Risperidone, an atypical antipsychotic, has been approved by the Food and Drug Administration for the treatment of schizophrenia in the adolescent population in the adolescent population. [5] Although atypical antipsychotic agents have improved outcomes in schizophrenia, their clinical potential remains limited by patients' nonadherence to medication. [6] Some of the patients with schizophrenia do not respond completely to treatment and only experience a partial improvement and remain functionally impaired. While medication has been found to be effective for the treatment of "positive" symptoms of the disease, treatment of the "negative symptoms" of schizophrenia (including lack of energy, motivation, and emotions) has historically not been very successful. [4, 5] MS14 is an Iranian herbal-marine compound that has been patented by invention and patent registration office of Islamic Republic of Iran (no: 29350) and classified as equivalent to food with no observable adverse effect level (NOAEL). [8, 9] According to analytic data this compound contains many inorganic salts or complexes and also trace elements such as bromine (Br), strontium (Sr), vanadium (V), titanium (Ti), nickel (Ni) and zinc (Zn). [10] Safety of MS14 has been confirmed by sub-acute toxicity studies in rats (clinical, histopathological, hematological and biochemical). [8] A study of MS14 in experimental allergic encephalomyelitis (EAE) model has shown that oral treatment of the EAE mice with MS14 not only halts the progression of the disease but also attenuates the inflammation in CNS indicating that this herbal-marine compound has anti-inflammatory effects [11].
Overall, alleviation of clinical and neurological symptoms in EAE mice by MS14 explained the beneficial effects of traditionally used MS14 in MS patients, an effect which could also be investigated in other groups of psychological and neurological diseases. Additionally, there are anecdotal but unconfirmed reports for the effectiveness of MS14 in patients with schizophrenia. In this regard, we have decided to perform a randomized placebo-controlled study on the effect of MS14 on schizophrenia, to assess the safety and efficacy of this compound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: MS14, Drug: RisperidoneThe 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 comparator | Drug: RisperidoneReceives 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No other concurrent diseases
- Signing the consent form by either the patient or their guardian
- Proved diagnosis of schizophrenia through SCID structured interview
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MS14MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months | Drug | treatment group |
| RisperidoneThe 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. | Drug | Control group, treatment group |
Primary outcome
response rate
Time frame: after the completion of three months of therapy
1 secondary outcome
CGI and PANSS questionnaires as well as a questionnaire designed for drug induced side effects will be filled weekly
Time frame: During the first six weeks of therapy, patients will be interviewed every week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
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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.
Seyed Vahid Shariat principal investigator
Department of Psychiatry and Mental Health Research Center, Iran University of Medical Sciences
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 MS14 and Risperidone in people with Schizophrenia, run by Farzan Institute at 1 site in Iran.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Mar 2010. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Vahid Shariat (+98-21-6650 6862, shariatv@iums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: after the completion of three months of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2010.