Phase 4 Completed N=60 Randomized Double-blind Treatment

The Effect of N-Acetyl Cysteine on Cortical Erosion in Early Stage Schizophrenia

Schizophrenia · Psychotic Disorder NOS · schizoaffective disorder · Schizophreniform

Source: ClinicalTrials.gov NCT01339858 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

May 2019

Primary outcomePrimary: Cortical Thickness — 2.53; 2.54; 2.51; 2.52 mm

Summary

The primary objective of this study is to determine if NAC, added to existing antipsychotic treatment, is superior to placebo for cortical erosion in patients with early stage psychosis. The primary hypothesis is that there will be significantly less cortical erosion as measured by cortical thickness, cortical volume and cortical white matter density (assessed by DTI) in patients treated for 12 months with NAC as compared to those treated with placebo. The secondary objectives of this study are to determine if 12 months of NAC add-on treatment is superior to placebo for fMRI determined working memory and semantic memory tasks, cortical MR spectroscopy measures (glutathione, N-acetylaspartate, and glutamine/glutamate levels), electrophysiologically determined attention measures (e.g., mismatch negativity, P300), symptoms, functional measures and cognitive functioning.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cortical Thickness	2.53; 2.54; 2.51; 2.52; 2.59; 2.57	—
PRIMARY Cortical Volume	233.0; 235.8; 423.8; 418.5	—
SECONDARY Working Memory	0.299; 0.356; 0.351; 0.398; 0.315; 0.406	—
SECONDARY Number of Participants With Glutamine/Glutamate Level Changes	18; 0	0.32
SECONDARY Attention Measures	3.81; 4.18; 2.96; 3.46; 0.37; 0.47	—
SECONDARY Symptoms of a Psychotic Disorder	2.78; 3.00	—
SECONDARY Cognitive Functioning	26.91; 27.70; 30.03; 29.37	—
SECONDARY Functional Status	62.51; 64.46; 64.51; 65.44	—
SECONDARY Mismatch Negativity Voltage Differences	-2.51; -3.44	—
SECONDARY Symptoms of a Psychotic Disorder	2.78; 3.00	—

Eligibility Criteria

SUBJECTS DIAGNOSED WITH A PSYCHOTIC DISORDER

Inclusion Criteria

Patients with a DSM-IV diagnosis of schizophrenia, schizophreniform, schizoaffective, psychosis disorder NOS
Age range 16-35 years
Male or female
Within 2 years of the first onset of psychotic symptoms that resulted in work/school/social dysfunction and/or treatment (PI will review potential subjects who have been experiencing symptoms >2 years but <5 years and will allow to enter the trial on a case-by-case basis)
Ability to provide informed consent and/or assent (all subjects)
For subjects 16 and 17 years of age, parental/guardian consent

Exclusion Criteria

Unstable medical conditions
Active seizure disorder
Pregnant or lactating women
Females unwilling to utilize birth control
Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt (because of MR studies).
Known IQ less than 70
DSM-IV-TR diagnosis of substance dependence (with the exception of nicotine or caffeine dependence)
Psychotic symptoms secondary to substance use
Considered a high risk for suicidal acts - active suicidal ideation with intent to act as determined by clinical interview

HEALTHY CONTROL SUBJECTS

The comparison subjects will consist of 40 healthy normal volunteers recruited from the community who will be age and gender matched to subjects diagnosed with a psychotic disorder entering the NAC treatment study

Inclusion Criteria

Age range of 18-30 (inclusive) and able to give voluntary informed consent (Note: Subjects diagnosed with a psychotic disorder under the age of 18 will be age matched to control subjects aged 18).
Male or Female

Exclusion Criteria

Current severe mental disorder (Schizophrenia, schizophreniform disorder, other psychotic disorders, bipolar disorder, major depressive disorder)
Known/documented IQ < 70
Pregnant or lactating women
Acute, serious, or unstable medical condition
Metallic implants or other contraindication to MRI (including but not limited to: Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt)
First degree relative with a psychotic disorder (i.e. schizophrenia, schizophreniform, schizoaffective, psychosis disorder NOS, substance induced psychosis, major depression with psychotic features, or bipolar disorder with psychotic features).
Current DSM-IV-TR diagnosis of substance abuse or dependence (with the exception of nicotine or caffeine) as diagnosed within the 6 months prior to screening visit
Known history of seizure disorder, head trauma, stroke, traumatic brain injury, significant loss of consciousness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01339858). 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. Informational only — not medical advice.