Is MS14 Helpful in Schizophrenia?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Farzan Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Farzan Institute
ClinicalTrials.gov Identifier:
NCT01083381
First received: March 8, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

In this study we want to find out whether MS14 - a herbal drug- can help Schizophrenia patients or not.


Condition Intervention Phase
Schizophrenia
Drug: MS14
Drug: Risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of MS14 in Association With Risperidone in Treatment of Schizophrenia: A Double Blind Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Farzan Institute:

Primary Outcome Measures:
  • response rate [ Time Frame: after the completion of three months of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment group
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.
Drug: MS14
MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months
Drug: Risperidone
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.
Placebo Comparator: Control group
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.
Drug: Risperidone
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No other concurrent diseases
  • Signing the consent form by either the patient or their guardian
  • Proved diagnosis of schizophrenia through SCID structured interview

Exclusion criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083381

Contacts
Contact: Seyed Vahid Shariat +98-21-6650 6862 shariatv@iums.ac.ir

Locations
Iran, Islamic Republic of
Iran Psychiatric Training and Treatment Center Recruiting
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Farzan Institute
Investigators
Principal Investigator: Seyed Vahid Shariat Department of Psychiatry and Mental Health Research Center, Iran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Gholamreza Habibi, Farzan Institute
ClinicalTrials.gov Identifier: NCT01083381     History of Changes
Other Study ID Numbers: 09123272376
Study First Received: March 8, 2010
Last Updated: March 8, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Farzan Institute:
Schizophrenia treatment MS14 randomized clinical trial

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014