This trial is active, not recruiting.

Condition schizophrenia
Treatments d-serine, placebo
Phase phase 2
Sponsor Nathan Kline Institute for Psychiatric Research
Start date August 2014
End date July 2016
Trial size 23 participants
Trial identifier NCT02156908, 601945


The investigators will first test, in a pilot study, the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm, and then do a small-scale double-blind study of DSR + SBR on auditory emotion recognition.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
D-serine 60 mg/kg

Primary Outcomes

Auditory Emotion recognition
time frame: six weeks

Secondary Outcomes

Mismatch negativity
time frame: six weeks
Tone matching threshold
time frame: three weeks
MATRICS consensus cognitive battery
time frame: six weeks

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion criteria: - 18 to 64 years old, - IQ≥85 and - estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry. Exclusion criteria: - history of neurological visual or hearing impairment, - active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), - current alcohol or drug abuse (<1 month) or substance dependence (<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.

Additional Information

Official title D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot and D-serine and Cognitive Remediation in Schizophrenia: Double Blind
Principal investigator Joshua T Kantrowitz, MD
Description We will initially enroll 5 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR. We will then enroll 20 individuals in a parallel group, double blind placebo controlled intervention. Subjects will be assigned to D-serine (60mg/kg) or placebo to be taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session. Subjects will under go three sessions of tone matching SBR, followed by 3 sessions of emotion recognition SBR. In total subjects will have 6 treatment sessions, and as before, treatment days will be separated by 1 week. Electrophysiology will be conducted at baseline and after the third weekly SBR session, and social cognitive and safety measures will also be completed at baseline and final. Double blind SBR intervention: First three sessions will be similar to SBR for pilot, with base tones limited to 100-400 Hz (emotionally relevant range). This will be followed by three sessions in which subjects are trained on identifying emotionally relevant tones. Tones will be developed based on previous research (Kantrowitz 2011). Kantrowitz JT, Leitman DI, Lehrfeld JM, Laukka P, Juslin PN, Butler PD, et al. Reduction in tonal discriminations predicts receptive emotion processing deficits in schizophrenia and schizoaffective disorder. Schizophrenia bulletin. 2013;39(1):86-93.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Nathan Kline Institute for Psychiatric Research.