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

NCT01354132 | Completed Phase 2 Results DMC

• 2 other identifiers: 2008P000460107865
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Schizophrenic Psychoses

Keywords

schizophrenia; schizoaffective; schizophreniform; early schizophrenia spectrum psychosis

Outcome Measures

Primary Outcomes (1)

• Change in Negative Symptoms of Schizophrenia as Measured on the PANSS

  Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 .

  at 6 months

Secondary Outcomes (20)

• Change in Positive Symptoms (PANSS)

  at 6 months

• Global Assessment of Functioning (GAF)

  at 6 months

• Social and Occupational Functioning Assessment Scale (SOFAS)

  at 6 months

• Change in Cognition and Working Memory (MATRICS) Speed of Processing

  at 6 months

• Change in Cognition and Working Memory (MATRICS) Working Memory

  at 6 months

Study Arms (2)

n-acetyl-cysteine

ACTIVE COMPARATOR

N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks

Drug: n-acetylcysteine

Placebo

PLACEBO COMPARATOR

matching effervescent tablets in water 2 in am and 1 in pm

Drug: Placebo

Interventions

n-acetylcysteine DRUG

900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM

Also known as: PharmaNAC

n-acetyl-cysteine

Placebo DRUG

Placebo tablets are placed in water or juice in the AM and PM

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Center de Neurosciences Psychiatrique, Lausanne, Switzerland: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts Mental Health Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Do KQ, Conus P, Cuenod M. Redox dysregulation and oxidative stress in schizophrenia: nutrigenetics as a challenge in psychiatric disease prevention. World Rev Nutr Diet. 2010;101:131-153. doi: 10.1159/000314518. Epub 2010 Apr 30. No abstract available.

  PMID: 20436260 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Larry Seidman, PhD
• Organization: Beth Israel Deaconess Medical Center

lseidman@bidmc.harvard.edu

617 754-1238

Study Officials

• Ann Cousins, PhD, APRN

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

• T. U. Wilson Woo, MD, PhD

  Harvard Medical School (HMS and HSDM)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 16, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 5, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-06

Locations

US (2)