Gabapentin in Patients at Clinical Risk for Psychosis
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|ClinicalTrials.gov Identifier: NCT02557945|
Recruitment Status : Terminated (Combination of insufficient funding and lack of compelling findings)
First Posted : September 23, 2015
Results First Posted : May 3, 2022
Last Update Posted : May 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Clinical High Risk for Psychosis||Drug: Gabapentin Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Gabapentin in Patients at Clinical Risk for Psychosis|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||June 12, 2016|
|Actual Study Completion Date :||June 12, 2016|
Gabapentin 3600mg PO daily
Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Placebo Comparator: Placebo
Matching placebo PO daily
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) [ Time Frame: 6 weeks ]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.
- 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) [ Time Frame: 6 weeks ]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.
- Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II) [ Time Frame: 6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557945
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Ragy Girgis, M.D.||NYSPI/Columbia|