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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02240173
Recruitment Status : Unknown
Verified February 2017 by Federal Neuro-Psychiatric Hospital, Yaba.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Federal Neuro-Psychiatric Hospital, Yaba

Tracking Information
First Submitted Date  ICMJE September 11, 2014
First Posted Date  ICMJE September 15, 2014
Last Update Posted Date February 16, 2017
Estimated Study Start Date  ICMJE June 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2014)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)		 Patient's general health and social functioning [ Time Frame: 8 Weeks ]
To be assessed using the Clinical Global Impression Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2014)		 Side effects [ Time Frame: 8 Weeks ]
This will be measured using a side-effect scale designed for the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
Official Title  ICMJE Phase 2 Study of the Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia and Disorders With Psychotic Features
Intervention  ICMJE
  • Dietary Supplement: Jobelyn
    Jobelyn is a dietary supplement made from Sorghum bicolor
    Other Name: Sorghum bicolor
  • Drug: Haloperidol
    Conventional drug normally used for psychotic problems
    Other Name: Haloperidol decanoate
Study Arms  ICMJE
  • Experimental: Jobelyn + Haloperidol
    Combination of the conventional drugs and Jobelyn
    Intervention: Dietary Supplement: Jobelyn
  • Active Comparator: Haloperidol + Placebo
    Combination of the conventional drug + Placebo
    Intervention: Drug: Haloperidol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2014)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240173
Other Study ID Numbers  ICMJE MOjo
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Federal Neuro-Psychiatric Hospital, Yaba
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federal Neuro-Psychiatric Hospital, Yaba
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moses Ojo, M.D. NPHY
PRS Account Federal Neuro-Psychiatric Hospital, Yaba
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP