SchizophreniaNCT02647437
Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia
A study testing Levetiracetam in people with Schizophrenia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy of low-dose LEV in reducing hippocampal activity in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- Good general health
- Normal vital signs (blood pressure, pulse, cardiac, pulmonary, abdominal, neurological exam)
- Normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available)
Who cannot join
- Substance abuse
- Significant neurological disorders
- Significant head trauma/injury
- Left-handedness
- Pregnancy
- MRI-specific exclusion criteria (e.g., claustrophobia, weight > 450lbs, metal in the body)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Patients With Schizophrenia
Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also hypothesize that LEV will improve neurocognition in participants with schizophrenia.
Read the detailed description
LEV is typically administered in twice-daily doses of 500-1500 mg for the treatment of epilepsy; these doses are generally well tolerated (Patsalos, 2000). Most relevant to the proposed study, LEV (125 mg twice-daily, two week administration) has been shown to reduce hippocampal hyperactivity and improves cognition in patients with mild cognitive impairment (MCI).
The proposed study will administer 125 mg of immediate release LEV twice-daily for two weeks. This dose was chosen to potentially maximize efficacy while minimizing side effects. The proposed dose is substantially lower than the most common dose used clinically for epilepsy treatment of 3000 mg/day.
- Conditions
- Schizophrenia
- Being tested
- Levetiracetam, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam, Then Placebo | Experimental | 2 weeks of levetiracetam administration (125 mg pill, bid), followed by a 1-2 week washout, then 2 weeks of placebo pill administration (bid). Receives: Drug: Levetiracetam; Drug: Placebo |
| Placebo, Then Levetiracetam | Experimental | 2 weeks of placebo pill administration (bid), followed by a 1-2 week washout, then 2 weeks of levetiracetam administration (125 mg pill, bid). Receives: Drug: Levetiracetam; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state Neuronal Response
Mean neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest. This was measured as fractional amplitude of low frequency fluctuations (fALFF), which is a metric derived from resting-state fMRI that represents the power of regional spontaneous, intrinsic brain activity. This was calculated as the ratio of the low-frequency band power (0.01-0.1 Hz) to the total power across the entire frequency range of the Blood Oxygen Level-Dependent (BOLD) signal. Values generally range from 0 to 1, with higher values indicating a larger fraction of low-frequency fluctuations.
Measured: 2 weeks
Secondary outcomes (1)
Neurocognitive Function
Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive test battery. The RBANS consists of 12 subtests; raw scores from the 12 subtests are converted into age-based standardized index scores (mean=100, standard deviation [SD]=15) across five cognitive domains (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). The five index scores are summed, then translated to a final total scale score (mean=100, SD=15) using the conversion table in the RBANS manual. RBANS total scores range from 40-160, with lower scores indicating worse cognitive function. Scores one SD below the mean of 100 are indicative of mild cognitive impairment or the lower end of normal cognitive function, scores two SDs below the mean suggest moderate cognitive impairment, and scores three SD below the mean suggest severe cognitive impairment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJun 2013
- Primary completionSep 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Tregellas, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647437
- Sponsor's protocol ID
- 13-1495
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2015
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No