A Phase 1/2 interventional study of Gabapentin and Placebo in Clinical High Risk for Psychosis, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Other
The purpose of this study is to test the effects of the drug gabapentin on brain function thought to be important in the development of schizophrenia. Researchers think that treating a brain region with gabapentin (the hippocampus) may reduce the risk for developing schizophrenia.
Six week, single site, proof-of concept, randomized double-blind placebo-controlled pilot study to examine the effects of moderate dose gabapentin (3600mg) in n= 100 putatively prodromal patients on hippocampal activity.
New York State Psychiatric Institute is the lead sponsor of 433 studies on the registry; 25 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Gabapentin 3600mg PO daily
Drug: Gabapentin
Matching placebo PO daily
Drug: Placebo
Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
Change from 6 week follow up minus baseline of left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment.
Time frame: 6 weeks
Change in Positive, Negative, Disorganization, and General Symptoms Over Time as Measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS)/the Scale of Psychosis-Risk Symptoms (SOPS)
Exploratory analyses will be conducted examining the effects of gabapentin on changes in Positive symptoms (P scores), negative symptoms (N scores) and general symptoms (G scores) and disorganization symptoms (D scores) compared to placebo. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score at baseline indicates less symptoms, and therefore a negative change over the 6 week period indicates an improvement, and a positive change indicates worsening of symptoms.
Time frame: 6 weeks
Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)
Exploratory analyses will be conducted on changes between gabapentin and placebo groups on the California Verbal Learning Test-Second Edition (CLVT-II) measures. The unit measured was 'learning slope', where higher slope indicates better memory and a lower slope indicates poorer memory.
Time frame: 6 weeks
9 individuals signed consent and underwent screening procedures for the study. 6 of the 9 were randomized to receive gabapentin/placebo
| Milestone | Gabapentin | Placebo |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
Change from 6 week follow up minus baseline of left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment.
| percent change | Gabapentin | Placebo |
|---|---|---|
| Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure) | -0.005 ± 0.388 | 0.38 ± 0.317 |
Exploratory analyses will be conducted examining the effects of gabapentin on changes in Positive symptoms (P scores), negative symptoms (N scores) and general symptoms (G scores) and disorganization symptoms (D scores) compared to placebo. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score at baseline indicates less symptoms, and therefore a negative change over the 6 week period indicates an improvement, and a positive change indicates worsening of symptoms.
| score on a scale | Gabapentin | Placebo |
|---|---|---|
| P score change | -1.5 (-2 to -1) | 0.66 (0 to 2) |
| N score change | -1 (-4 to 2) | -1.66 (-5 to 3) |
| G score change | -1.5 (-2 to -1) | 0.5 (0 to 1) |
| D score change | 2 (1 to 3) | -2.5 (-5 to 0) |
Exploratory analyses will be conducted on changes between gabapentin and placebo groups on the California Verbal Learning Test-Second Edition (CLVT-II) measures. The unit measured was 'learning slope', where higher slope indicates better memory and a lower slope indicates poorer memory.
| Change in raw learning slope | Gabapentin | Placebo |
|---|---|---|
| Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II) | 0.1 (0.1 to 0.1) | -0.3 (-0.6 to 0.2) |
Collected over From consent to completion of participation (approximately 42 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Placebo | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Gabapentin | Placebo |
|---|---|---|
| paresthesiasNervous system disorders | 1/3 | 0/3 |
Baseline population are the individuals who received gabapentin or placebo and underwent MRI procedures
| Age, Categorical(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 3 | 2 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin
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