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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)

Must not have

Renal insufficiency (if serum creatinine is greater than laboratory limits for normal, estimated creatinine clearance must be greater than 80)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit (week 0), week 6 visit, week 12 visit

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is good, with creatinine clearance over 80.

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I do not have a significant illness like seizures or a history of serious head injuries.

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I have been diagnosed with a major mood or mental health disorder, but not Schizophrenia or related conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit (week 0), week 6 visit, week 12 visit

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The symptoms measured by the BPRS total score

Secondary study objectives

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.

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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.

0 / 5Eligibility criteria met