Phase 2
N=16
N-acetylcysteine and NMDA Antagonist Interactions
Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00611897 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Target P300 — 2.5; 3.2; 5.2; 3.4 microvolts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine and ketamine (Drug); placebo and ketamine (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target P300 |
2.5; 3.2; 5.2; 3.4; 7.7; 5.5 | — |
| PRIMARY Novel P300 |
5.6; 5.2; 7.6; 5.3; 10.5; 7.0 | — |
| SECONDARY Mismatch Negativity (MMN) Intensity |
-3.5; -2.7; -3.4; -2.6; -3.2; -2.5 | — |
| SECONDARY Mismatch Negativity (MMN) Frequency |
-3.3; -2.7; -3.1; -2.9; -3.3; -2.7 | — |
| SECONDARY Mismatch Negativity (MMN) Duration |
-3.2; -3.1; -3.2; -2.8; -3.1; -3.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00611897). 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.