Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia

February 14, 2017 updated by: Federal Neuro-Psychiatric Hospital, Yaba

Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.

Sorghum bicolor is a naturally growing plant which has been of health benefit to the people of West Africa who traditionally prepare its leaf for various nutritional and health reasons.The food and nutritional fact analysis showed that Jobelyn is rich in Carbohydrates, Protein, Dietary Fiber, Iron, Natural Vitamins like B12 and Vitamin C. It also contains Selenium, Omega 3,6 and 9 and other essential elements and fatty acids. Although the determinants of mental health are complex, the emerging and compelling evidence for nutrition as a crucial factor in the high prevalence and incidence of mental disorders suggests that diet is as important to psychiatry as it is to cardiology, endocrinology, and gastroenterology. Evidence is steadily growing for the relation between dietary quality (and potential nutritional deficiencies) and mental health, and for the select use of nutrient-based supplements to address deficiencies, or as monotherapies or augmentation therapies. There is currently strong advocacy for the recognition of diet and nutrition as central determinants of both physical and mental health.Its anti-inflammatory and haematocrit boosting properties have been well documented though the precise mechanism of action is still largely unknown. Its use has recently been extended to the field of mental health where findings in animal study suggest it could be of help in relieve of psychosis. The need for this study is therefore aimed at investigating the effect of this drug in patients with schizophrenia which is the prototypical psychotic disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is a major psychiatric disorder with a chronic and debilitating course. It is the archetypal psychotic disorder with a prevalence of about 1% worldwide. The treatment of this psychotic disorder has evolved over the years after the discovery of Chlorpromazine. Despite the availability of several treatment options in practice, research into the possibility of creating a drug breakthrough continues.

Sorghum bicolor, a naturally growing plant rich in several phytochemical including proanthocyanidins, anthocyanidins, apigenin, proapigeninidin, apigeninidin, luteolin, naringenins, flavonoids, and polyphenols (Omogbiya et al 2012) and prepared as a capsule called Jobelyn. This plant has been found to be of health benefit to the people of West Africa who traditionally prepare its leaf for various nutritional and health reasons. The anti-inflammatory and haematocrit boosting properties have been well documented and utilized though the precise mechanism of action is still not entirely known (Benson et al. 2013). Its usefulness in neuropsychiatric conditions has recently been explored albeit through animal studies.

In animals, Jobelyn has been suggested to have anti-amnestic property which has been suggested to be related to its antioxidant activity (Umukoro et al. 2013a). Other studies also suggested that Jobelyn has an anti-aggressive effect (Umukoro et al. 2012) and antidepressant like property probably related to its stimulation of serotonergic pathways (Umukoro et al. 2013b). Jobelyn has also been suggested to exhibit anti-psychotic-like activity with the benefit of lacking extra-pyramidal side effect risks and therefore being postulated to be of possible benefit in the symptomatic relief of psychosis (Omogbiya et al. 2012).

There is however limited information in terms of the suggested neuropsychiatric conditions especially in humans despite the recognized safety profile consequent upon its use as haematocrit boosting agent. This study therefore aims at exploring the usefulness of Jobelyn in the treatment of patients with Schizophrenia as an adjunct to standard treatment.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
      • Lagos, Nigeria, 101212
        • Federal Neuro-Psychiatric Hospital Yaba - Lagos
        • Sub-Investigator:
          • Adefemi A Adeoye, M.D.
        • Sub-Investigator:
          • I I Adeosun, M. D..
        • Sub-Investigator:
          • O S Oluwaniyi, M.D.
        • Sub-Investigator:
          • J A Kajero, M.D.
        • Sub-Investigator:
          • T O Oduguwa, M.D.
        • Sub-Investigator:
          • T A Adewumi, M.D.
        • Sub-Investigator:
          • A A Adegbohun, M.D.
        • Sub-Investigator:
          • O H Famurewa, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants will be adults with current diagnosis of schizophrenia (meeting the ICD-10 criteria).

  • Adults who are above 18 years of age and gave informed consent
  • Currently meet the ICD-10 diagnosis of Schizophrenia and confirmed with MINI- PLUS
  • Antipsychotic naive before recruitment into study or defaulted from treatment for at least 6 months 'prior to contact with study
  • Not on Jobelyn or Megafit currently or in the past 6months prior to contact with study

Exclusion Criteria:

  • Having another current ICD-l0 diagnosis or a seizure disorder
  • Serious or chronic physical illness
  • Known severe drug allergies or hypersensitivity to Jobelyn, Megafit or Haloperidol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jobelyn + Haloperidol
Combination of the conventional drugs and Jobelyn
Dietary supplement: Jobelyn
Jobelyn is a dietary supplement made from Sorghum bicolor
Other Names:
  • Sorghum bicolor
Active Comparator: Haloperidol + Placebo
Combination of the conventional drug + Placebo
Drug: Haloperidol
Conventional drug normally used for psychotic problems
Other Names:
  • Haloperidol decanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be the changes in psychotic symptoms
Time Frame: 8 Weeks
This will be rated using the Brief Psychiatric Rating Scale (BPRS).
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's general health and social functioning
Time Frame: 8 Weeks
To be assessed using the Clinical Global Impression Scale.
8 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 8 Weeks
This will be measured using a side-effect scale designed for the study
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Neuro-Psychiatric Hospital, Yaba

Investigators

  • Principal Investigator: Moses Ojo, M.D., NPHY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOjo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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