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Levetiracetam for Early Psychosis

Phase 2
Recruiting
Led By Donald Goff
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females 16 to 40 years of age, inclusive, at time of informed consent
Must have a diagnosis of either schizophrenia, schizoaffective disorder or schizophreniform disorder as established by a Structured Clinical Interview for DSM-V (SCID)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit (week 0), week 6 visit, week 12 visit
Awards & highlights

Study Summary

This trial is testing whether adding the medication Keppra to standard antipsychotic treatment can improve symptoms and protect against brain volume loss in patients with early psychosis.

Who is the study for?
This trial is for individuals aged 16-40 who have had a first episode of nonaffective psychosis within the last 5 years and still experience symptoms despite taking antipsychotics for at least 8 weeks. Participants must not be pregnant, nursing, or planning pregnancy and should agree to use birth control. Exclusions include substance abuse (except nicotine/THC), major mood disorders other than schizophrenia spectrum disorders, significant medical conditions, or contraindications to MRI.Check my eligibility
What is being tested?
The study tests if adding levetiracetam (an epilepsy drug) to standard antipsychotic treatment helps improve persistent psychotic symptoms in early psychosis patients. It's a comparison between levetiracetam pills and placebo over a period of 12 weeks with participants randomly assigned to either group.See study design
What are the potential side effects?
Levetiracetam may cause side effects such as drowsiness, weakness, dizziness, infection risk increase due to immune system changes, mood swings including aggression or agitation, coordination problems leading to falls or injuries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 40 years old.
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I have been diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit (week 0), week 6 visit, week 12 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit (week 0), week 6 visit, week 12 visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The symptoms measured by the BPRS total score
Secondary outcome measures
Compare to placebo, levetiracetam will improve negative symptoms measured by the modified SANS total score.
Compared to placebo, levetiracetam will be associated with less hippocampal volume loss over 12 weeks.
Compared to placebo, levetiracetam will improve cognitive functioning measured by the MATRICS composite score.
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Study Drug groupActive Control1 Intervention
Participants in this group will receive 500 mg of levetiracetam twice daily for 12 weeks. After 12 weeks, levetiracetam will be gradually decreased and stopped over the next 9 days. Questionnaires will be administered at each visit to examine how participants are responding to the treatment. In addition, a brain scan and cognitive testing will be performed when feasible at the beginning and the end of the study.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants in this group will receive a placebo that looks like the levetiracetam pill twice daily for 12 weeks. After 12 weeks, the levetiracetam dose will be tapered for the next 9 days. Questionnaires will be administered at each visit to examine how participants are responding to the treatment. In addition, a brain scan and cognitive testing will be performed when feasible at the beginning and the end of the study.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,551 Total Patients Enrolled
2 Trials studying Psychosis
348 Patients Enrolled for Psychosis
Donald GoffPrincipal InvestigatorNYU Langone Health

Media Library

Study Drug group Clinical Trial Eligibility Overview. Trial Name: NCT04317807 — Phase 2
Psychosis Research Study Groups: Placebo Group, Study Drug group
Psychosis Clinical Trial 2023: Study Drug group Highlights & Side Effects. Trial Name: NCT04317807 — Phase 2
Study Drug group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04317807 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for participation in this trial set at 45 years or above?

"This research study requires potential participants to be between 16 and 40 years old. There are 120 trials for minors and 271 studies specifically focusing on those over 65."

Answered by AI

Could I be a suitable participant in this research?

"This medical experiment is accepting 84 applicants suffering from psychological maladies, aged between 16 and 40. Essential prerequisites to participate include: having experienced a first episode of non-affective psychosis within the past five years; currently experiencing psychotic symptoms (as indicated by a score of ≥ 4 on one or more BPRS items); taking antipsychotic medication for at least 8 weeks with no dose changes in the previous month; abstaining from nursing/pregnancy during study period or using reliable contraception until termination."

Answered by AI

Has there been any prior research conducted with regard to the Study Drug cohort?

"Presently, there are 18 studies being conducted on the efficacy of Study Drug group; 2 of which have entered Phase 3. Despite originating in Brisbane, Queensland, these trials now span 40 different medical centres around the world."

Answered by AI

What is the current participation rate of this trial?

"Affirmative. According to information present on clinicaltrials.gov, this medico-legal research is actively recruiting participants and was posted August 1st 2020 with an edit made October 27th 2022. 84 individuals need to be recruited from just one centre for the trial's completion."

Answered by AI

Is application still available for prospective participants?

"Affirmatively, the clinical trial is still recruiting participants. Its original post date was on August 1st 2020 and its most recent edit was made October 27th 2022 according to information provided by clinicaltrials.gov."

Answered by AI

Has the Study Drug group gained Food and Drug Administration recognition?

"Although there is evidence of Study Drug group's safety, the lack of efficacy data leads to a score of 2 on Power team's scale."

Answered by AI

What therapeutic purposes is Study Drug group commonly employed for?

"Study Drug group can assist those with juvenile myoclonic epilepsy, who weigh more than 20 kilograms and have epilepsies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
R33: Levetiracetam in Early Psychosis
2020. "R33: Levetiracetam in Early Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04317807.
All > Mental Illness
~13 spots leftby Jan 2025
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