Trial Outcomes & Findings for Gabapentin in Patients at Clinical Risk for Psychosis (NCT NCT02557945)
NCT ID: NCT02557945
Last Updated: 2022-05-03
Results Overview
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.
TERMINATED
PHASE1/PHASE2
9 participants
6 weeks
2022-05-03
Participant Flow
9 individuals signed consent and underwent screening procedures for the study. 6 of the 9 were randomized to receive gabapentin/placebo
Participant milestones
| Measure |
Gabapentin
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
Matching placebo PO daily
Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin in Patients at Clinical Risk for Psychosis
Baseline characteristics by cohort
| Measure |
Gabapentin
n=3 Participants
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
n=3 Participants
Matching placebo PO daily
Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: While 6 participants received gabapentin or placebo, 1 participant data was excluded due to low quality of scans. Only 5 participants data were analyzes (2 in gabapentin group, 3 in placebo group)
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.
Outcome measures
| Measure |
Gabapentin
n=2 Participants
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
n=3 Participants
Matching placebo PO daily
Placebo: 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)
|
-0.005 percent change
Standard Error 0.388
|
0.38 percent change
Standard Error 0.317
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: For general symptom score (G score) and disorganization symptom (D score), 1 participant had missing data and was not included in the data reporting.
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.
Outcome measures
| Measure |
Gabapentin
n=2 Participants
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
n=3 Participants
Matching placebo PO daily
Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
|---|---|---|
|
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)
N score change
|
-1 score on a scale
Interval -4.0 to 2.0
|
-1.66 score on a scale
Interval -5.0 to 3.0
|
|
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)
G score change
|
-1.5 score on a scale
Interval -2.0 to -1.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
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)
D score change
|
2 score on a scale
Interval 1.0 to 3.0
|
-2.5 score on a scale
Interval -5.0 to 0.0
|
|
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)
P score change
|
-1.5 score on a scale
Interval -2.0 to -1.0
|
0.66 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 6 weeksExploratory 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.
Outcome measures
| Measure |
Gabapentin
n=2 Participants
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
n=3 Participants
Matching placebo PO daily
Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
|---|---|---|
|
Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)
|
0.1 Change in raw learning slope
Interval 0.1 to 0.1
|
-0.3 Change in raw learning slope
Interval -0.6 to 0.2
|
Adverse Events
Gabapentin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=3 participants at risk
Gabapentin 3600mg PO daily
Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
Placebo
n=3 participants at risk
Matching placebo PO daily
Placebo: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
|
|---|---|---|
|
Nervous system disorders
paresthesias
|
33.3%
1/3 • Number of events 1 • From consent to completion of participation (approximately 42 days)
|
0.00%
0/3 • From consent to completion of participation (approximately 42 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place