Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorders
Conditions
Keywords
Schizophrenia, Sodium Benzoate, N-Acetylcysteine, NMDA receptor, Psychopharmacology, Anti-oxidant, Inflammation
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.
Interventions
DRUGSodium Benzoate
Sodium Benzoate will be administered at 1000mg daily
DRUGN-Acetylcysteine
N-Acetylcysteine 1000 mgs twice daily dose
DRUGPlacebo
Placebo added to TAU
DRUGSodium Benzoate Plus N-Acetylcysteine
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Sponsors
Pakistan Institute of Living and Learning
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind placebo controlled trial
Intervention model description
This will be a 2x2 factorial design trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention ( including recruitment rates and drop outs) | Recruitment within 12 months of study start start date | Feasibility estimates of delivering the intervention including recruitment rates and drop outs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score | change in scores from Baseline to 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in positive and/or negative symptoms subscales measured using the PANSS. | change in scores from Baseline to 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. |
| Improvement on Clinical Global Impression (CGI) Scale and Social and Occupational Functioning Assessment (SOFA) scales. | change in scores from Baseline to 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 |
| Improvement in cognitive functioning as measured using CogState Schizophrenia Battery. | change in scores from Baseline to 12 weeks | — |
Countries
Pakistan
Outcome results
None listed