Clinical trial NCT01232790: A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia
Official title: A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
working memory
N-Acetylcysteine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2010-11-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve performance of patients with schizophrenia on a battery of cognitive tasks utilized to test working memory and other cognitive domains, versus placebo. This pilot study will utilize a randomized, double blind, placebo controlled, crossover design.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: BACS Composite RAW Score
timeFrame: Baseline
measure: BACS Composite RAW Score
timeFrame: Follow Up (5 days)
measure: BACS Composite RAW Score
timeFrame: Change from Baseline at Follow Up (5 days)
measure: BACS Composite RAW Score
timeFrame: Baseline 1st Leg of Crossover
measure: BACS Composite RAW Score
timeFrame: Follow Up 1st Leg of Crossover (5 Days)
measure: BACS Composite RAW Score
timeFrame: Baseline 2nd Leg of Crossover
measure: BACS Composite RAW Score
timeFrame: Follow Up 2nd Leg of Crossover (5 Days)
Secondary outcomes:
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Baseline
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Follow Up (5 days)
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Change from Baseline at Follow Up (5 days)
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Baseline 1st Leg of Crossover
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Follow Up 1st Leg of Crossover (5 Days)
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Baseline 2nd Leg of Crossover
measure: Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.
timeFrame: Follow Up 2nd Leg of Crossover (5 Days)
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Baseline
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Follow Up (5 days)
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Change from Baseline at Follow Up (Baseline - Follow Up)
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Baseline 1st Leg of Crossover
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Follow Up 1st Leg of Crossover (5 Days)
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Baseline 2nd Leg of Crossover
measure: Brief Visuospatial Memory Test (BVMT) RAW SCORE.
timeFrame: Follow Up 2nd Leg of Crossover (5 Days)
measure: Brief Psychiatric Rating Scale (BPRS)Total Score
timeFrame: Pre Screening
measure: Brief Psychiatric Rating Scale (BPRS)Total Score
timeFrame: End of Trial
measure: Brief Psychiatric Rating Scale (BPRS)Total Score
timeFrame: Change from PreScreening at End of Trial
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Cenk Tek, MD
role: PRINCIPAL_INVESTIGATOR
References: