N-acetylcysteine and NMDA Antagonist Interactions

NCT ID: NCT00611897

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-02-28

Brief Summary

This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.

Conditions

Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

Arm I

The NAC capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after NAC administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN).

Group Type: ACTIVE_COMPARATOR

N-acetylcysteine and ketamine

Intervention Type: DRUG

Active drug (N-acetylcysteine)

Arm II

The placebo capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after placebo administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN).

Group Type: PLACEBO_COMPARATOR

placebo and ketamine

Intervention Type: DRUG

placebo N-acetylcysteine

Interventions

N-acetylcysteine and ketamine

Active drug (N-acetylcysteine)

Intervention Type: DRUG

placebo and ketamine

placebo N-acetylcysteine

Intervention Type: DRUG

Other Intervention Names

NAC

Eligibility Criteria

Inclusion Criteria

• Ages of 21-45 years from all ethnic backgrounds.
• Male or female.
• Written informed consent.

Exclusion Criteria

• DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
• A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test) .
• History of severe allergies or multiple adverse drug reactions.
• Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures.
• Any other conditions which in the opinion of the investigator would preclude participation in the study.
• History of major psychiatric disorder in first degree relatives.
• Current substance abuse/dependency determined by urine toxicology.
• Current treatment with medications with psychotropic effects.
• Treatment with benzodiazepines within one week prior to testing.
• Current pregnancy, unsatisfactory birth control method report for females.
• Education < 10th grade.
• IQ < 70, MR as determined by Wechsler Abbreviated Scale of Intelligence.
• Non-English speaking.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Handan Gunduz-Bruce, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VHA Connecticut

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

0508000518

Identifier Type: -

Identifier Source: org_study_id