Using levetiracetam to treat early psychosis
A 12-week Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis
This study is testing if adding levetiracetam to treatment can help people with early psychosis who haven't responded well to their current medication feel better and protect their brain health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04317807 on ClinicalTrials.gov |
What this trial studies
This 12-week study investigates the effects of adding levetiracetam to a second-generation antipsychotic in patients with early psychosis who have not responded adequately to antipsychotic treatment. Participants will be randomized to receive either levetiracetam or a placebo, and their symptoms and cognitive performance will be assessed throughout the study. Additionally, brain imaging will be conducted to evaluate changes in hippocampal volume integrity. The goal is to determine if levetiracetam can improve psychotic symptoms and protect against brain atrophy.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 16 to 40 who have experienced a first episode of nonaffective psychosis within the last 5 years and continue to exhibit psychotic symptoms despite prior antipsychotic treatment.
Not a fit: Patients who have not experienced a first episode of psychosis or those who have been ill for more than 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with early psychosis who are not responding to standard antipsychotic medications.
How similar studies have performed: Other studies have explored the use of levetiracetam in various psychiatric conditions, but this specific approach in early psychosis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Males and females 16 to 40 years of age, inclusive, at time of informed consent * Must have experienced a first episode of nonaffective psychosis within 5 years and exhibit current psychosis, as defined by a score of ≥ 4 on one of the following psychosis items on the BPRS: conceptual disorganization, suspiciousness, hallucinations, unusual thought content, or grandiosity, for at least 4 days per week for at least 4 weeks * Must have a diagnosis of either schizophrenia, schizoaffective disorder or schizophreniform disorder as established by a Structured Clinical Interview for DSM-V (SCID) * Must have taken antipsychotic medication for a minimum of 8 weeks and at a stable dose for at least 4 weeks prior to randomization * If assigned female at birth and of childbearing potential, patients must: * Have a negative urine pregnancy test (all participants assigned female at birth regardless of childbearing potential will be required to submit a pregnancy test) and * Not be nursing or planning a pregnancy for the duration of the study through 30 days after the last dosing visit and * Be abstinent or willing to use a reliable method of birth control from the screening visit and continue with the same method until termination from the study Exclusion Criteria * Current substance abuse or dependence for substances other than nicotine and THC (i.e. alcohol, amphetamines, barbiturates) * A positive urine toxic screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed)) * Moderate or severe cannabis use disorder * Diagnosis of major mood disorder or other Axis I disorder other than Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder * Current suicidal ideation. Suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the suicidal ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the Principal Investigator * Pregnant, nursing or positive urine pregnancy test * Significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation * Renal insufficiency (if serum creatinine is greater than laboratory limits for normal, estimated creatinine clearance must be greater than 80) * Contraindications to MRI: metal implants, pacemaker, or other metal in the body, or claustrophobia. Individuals with tattoos will be excluded from imaging if tattoos cover more than 5% of the body surface, if a tattoo is greater than 20 cm, or if the tattoo is located on the face, neck or genitals. (Individuals with a contraindication to MRI may participate in the trial but will be excluded from the elective MRI component) * Significant history of serious violence * For both inpatient and outpatient subjects, a history of serious violence as assessed by the Buss-Perry Aggression Questionnaire * For outpatient subjects only, a score of 5 (moderately severe) or higher on the BPRS hostility item at screening or baseline
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Donald Goff — NYU Langone Health
- Study coordinator: Gillian Capichioni
- Email: gillian.capichioni@nyulangone.org
- Phone: 917-628-0552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.