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Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.

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ClinicalTrials.gov Identifier: NCT03510741
Recruitment Status : Not yet recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Brief Summary:
This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be acceptable and tolerable and result in overall improvement of symptoms, social and cognitive functioning in patients with early schizophrenia spectrum disorder.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorders Schizoaffective Disorder Drug: Sodium Benzoate Drug: N-Acetylcysteine Drug: Placebo Drug: Sodium Benzoate Plus N-Acetylcysteine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This will be a 2x2 factorial design trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind placebo controlled trial
Primary Purpose: Other
Official Title: A Multicentre 12-week Randomised Double-blind Placebo Controlled Feasibility Trial of Sodium Benzoate and/or N-acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Sodium Benzoate
Sodium Benzoate added to TAU will be administered at 1000mg daily
Drug: Sodium Benzoate
Sodium Benzoate will be administered at 1000mg daily

Active Comparator: N-Acetylcysteine
N-Acetylcysteine added to TAU 1000 mgs twice daily dose
Drug: N-Acetylcysteine
N-Acetylcysteine 1000 mgs twice daily dose

Active Comparator: Placebo
Placebo added to TAU
Drug: Placebo
Placebo added to TAU

Active Comparator: Sodium Benzoate Plus N-Acetylcysteine
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Drug: Sodium Benzoate Plus N-Acetylcysteine
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose




Primary Outcome Measures :
  1. Feasibility of intervention ( including recruitment rates and drop outs) [ Time Frame: 12 weeks ]
    Feasibility estimates of delivering the intervention including recruitment rates and drop outs


Secondary Outcome Measures :
  1. Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 12 weeks ]
    The PANSS is measured on a 7-point scale, and is a 30-item structured clinical interview assessing symptom severity over the previous week. The PANSS scale has a maximum score of 210 and a minimum of 30. Higher scores indicate higher severity of illness.


Other Outcome Measures:
  1. Improvement in positive and/or negative symptoms subscales measured using the PANSS. [ Time Frame: 12 weeks ]
    The PANSS is measured on a 7-point scale, and is a 30-item structured clinical interview assessing symptom severity over the previous week. The PANSS scale has a maximum score of 210 and a minimum of 30. Higher scores indicate higher severity of illness.

  2. Improvement on Clinical Global Impression (CGI) Scale and Social and Occupational Functioning Assessment (SOFA) scales. [ Time Frame: 12 weeks ]
    Clinical Global Impression (CGI) Scale is an observer rated clinical severity measure. The minimum score is 1 and maximum 7. Higher scores indicate severity of illness. Social and Occupational Functioning Assessment (SOFA) scale is a measure of current functioning, with scores ranging from 0 to 100. Higher scores represent higher functioning

  3. Improvement in cognitive functioning as measured using CogState Schizophrenia Battery. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/Female patients aged between 18-35 years.
  2. Diagnosis of schizophrenia confirmed by SCID interview meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
  3. Stable on medication for the past four weeks
  4. In contact with mental health services
  5. Within 5 years of diagnosis of psychotic illness
  6. Able to demonstrate the capacity to provide informed consent as assessed by their own clinician
  7. Able to complete the required evaluations and take oral medication.
  8. Effective contraceptive precautions (either the use of barrier methods or the oral contraceptive pill) to be taken by women of child-bearing age. A negative pregnancy test will be required in order to meet inclusion criteria.

Exclusion Criteria:

  1. Prior history of intolerance or serious side effects to Sodium Benzoate or N-acetylcystine.
  2. Concomitant use of Ascorbic acid
  3. Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-V criteria.
  4. Relevant CNS or other medical disorders.
  5. Pregnant or breast feeding
  6. Diagnosis of Moderate to Severe Learning Disability
  7. Relevant current or past haematological, hepatic, renal, neurological or other medical disorder in the opinion of the principal investigator (PI) or the responsible clinician, that may interfere with the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510741


Contacts
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Contact: Ameer B Khoso 021-35871845 ameer.bukhsh@pill.org.pk

Locations
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Pakistan
Balochistan Institute of Behavioral Science Not yet recruiting
Quetta, Balochistan, Pakistan
Contact: Prof. Ghulam Rasool         
Institute of Psychiatry, Rawalpindi Not yet recruiting
Rawalpindi, Islamabad, Pakistan
Contact: Prof. Fareed A Minhas         
Abbasi Shaheed Hsopital Not yet recruiting
Karachi, Sindh, Pakistan
Contact: Dr. Sohail Ahmed         
Civil Hospital Karachi Not yet recruiting
Karachi, Sindh, Pakistan
Contact: Prof. Raza Ur Rehman         
Karwan e Hayat Not yet recruiting
Karachi, Sindh, Pakistan
Contact: Dr. Ajmal Kazmi         
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Investigators
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Principal Investigator: Imran B Chaudhry, MD Ziauddin Hospital

Publications:

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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT03510741     History of Changes
Other Study ID Numbers: PILL-Sodium Benzoate & NAC-001
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pakistan Institute of Living and Learning:
Schizophrenia
Sodium Benzoate
N-Acetylcysteine
NMDA receptor
Psychopharmacology
Anti-oxidant
Inflammation
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Acetylcysteine
Sodium Benzoate
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Antifungal Agents