A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia

NCT01232790 | Completed Results

• 2 other identifiers: 0904005039M131976
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of the amino acid supplement N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; working memory; N-Acetylcysteine

Outcome Measures

Primary Outcomes (7)

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Baseline

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Follow Up (5 days)

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Change from Baseline at Follow Up (5 days)

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Baseline 1st Leg of Crossover

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Follow Up 1st Leg of Crossover (5 Days)

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Baseline 2nd Leg of Crossover

• BACS Composite RAW Score

  The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition. The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable.

  Follow Up 2nd Leg of Crossover (5 Days)

Secondary Outcomes (17)

• Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.

  Baseline

• Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.

  Follow Up (5 days)

• Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.

  Change from Baseline at Follow Up (5 days)

• Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.

  Baseline 1st Leg of Crossover

• Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.

  Follow Up 1st Leg of Crossover (5 Days)

Study Arms (2)

Group A: Intervention/Placebo

EXPERIMENTAL

Group A first receives the commercially available sustained release form of N-acetylcysteine, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).

Dietary Supplement: N-Acetylcysteine

Group B: Placebo/Intervention

PLACEBO COMPARATOR

Group B first receives the placebo and then receives a commercially available sustained release form of N-Acetylcysteine. In each arm, the capsules are both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).

Drug: Placebo

Interventions

N-Acetylcysteine DIETARY_SUPPLEMENT

N-acetylcysteine 1200mg bid for 3 days

Group A: Intervention/Placebo

Placebo DRUG

Placebo

Group B: Placebo/Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be between 18-60
• Meet Diagnostic and Statistical Manual-IV (DSM) criteria for schizophrenia
• Be on a stable dose of antipsychotic medication for at least 1 month
• Be deemed clinically stable for 3 months by the regular clinical staff

You may not qualify if:

• Current substance or alcohol abuse
• Pregnancy
• Clozapine treatment
• Known sensitivity to sulphur containing compounds
• Previous diagnosis of mental retardation
• Nitroglycerin use
• Asthma diagnosis, verified and treated by a primary care doctor
• Use of any other medication that may interact with the study medication

Sponsors & Collaborators

• Yale University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

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: Cenk Tek MD, Associate Professor of Psychiatry; Director, Psychosis Program, CMHC
• Organization: Yale University School of Medicine, Department of Psychiatry

cenk.tek@yale.edu

(203) 974-7484

Study Officials

• Cenk Tek, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: November 2, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 1, 2015
• Results First Posted: April 16, 2014

Record last verified: 2015-11

Locations

US (1)