Phase 2 N=63 Randomized Triple-blind Treatment

N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis

Schizophrenic Psychoses

Bottom Line

View on ClinicalTrials.gov: NCT01354132 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Change in Negative Symptoms of Schizophrenia as Measured on the PANSS — 16.9; 17.2 units on a scale — p=0.50

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: n-acetylcysteine (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Negative Symptoms of Schizophrenia as Measured on the PANSS	16.9; 17.2	0.50
SECONDARY Change in Positive Symptoms (PANSS)	13.7; 12.5	0.39
SECONDARY Global Assessment of Functioning (GAF)	52.2; 53.8	0.52
SECONDARY Social and Occupational Functioning Assessment Scale (SOFAS)	54.6; 54.8	0.71
SECONDARY Change in Cognition and Working Memory (MATRICS) Speed of Processing	41.47; 35.85	0.022 sig
SECONDARY Change in Cognition and Working Memory (MATRICS) Working Memory	47.47; 38.08	0.270
SECONDARY Change in Cognition and Working Memory (MATRICS) Attention and Vigilance	40.92; 30.40	0.153
SECONDARY Change in Cognition and Working Memory (MATRICS) Verbal Learning	42.18; 44.62	0.876
SECONDARY Change in Cognition and Working Memory (MATRICS) Visual Learning	46.00; 47.75	0.464
SECONDARY Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving	51.13; 44.38	0.741
SECONDARY Change in Blood Level of Glutathione	0.92; 0.82	0.05
SECONDARY Blood Plasma Level of Cysteine	229.6; 246.5	0.33
SECONDARY GPxbc Glutathione Peroxidase Activity in Blood Cells	21.24; 21.01	0.90
SECONDARY Glutamine Brain Level for NAC Group	3.16	0.6732
SECONDARY Glutamine Brain Level for Placebo Group	2.90	0.8786
SECONDARY Glutamate Brain Level for NAC Group	10.25	0.5622
SECONDARY Glutamate Brain Level for Placebo Group	10.65	0.9574
SECONDARY Glutathione Brain Level for NAC Group	1.04	0.0043 sig
SECONDARY Glutathione Brain Level for Placebo Group	1.05	0.3804
SECONDARY Myo-Inositol Brain Level for the NAC Group	6.27	0.9403
SECONDARY Myo-Inositol Brain Level for Placebo Group	6.26	0.9215

Summary

The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance. Aims: Does add-on NAC treatment in early psychosis influence: * positive and negative symptoms * extrapyramidal side-effects of other medication * plasma concentration of glutathione * Mismatch Negativity, a physiological marker

Eligibility Criteria

Inclusion Criteria

Capacity to provide informed consent
DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective
Psychiatric and medical stability
Prescribing clinician's premission to participate, assurance of medical stability
Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale
Up to 12 months of antipsychotic treatment

Exclusion Criteria

Severe medical comorbidities
Previous cerebral trauma
Substance induced psychosis or organic psychosis
Mental retardation
NAC allergy
Pregnancy, females and males planning pregnancy
Treatment with antioxidants
Insufficient command of English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01354132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.