Gabapentin in Patients at Clinical Risk for Psychosis

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02557945
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical High Risk for Psychosis	Drug: Gabapentin; Drug: Placebo	Phase 1/Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Gabapentin in Patients at Clinical Risk for Psychosis
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jun 12, 2016
• Actual Study Completion Date: Jun 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin Gabapentin 3600mg PO daily	Drug: Gabapentin; 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	Drug: Placebo; Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)

Outcome Measures

Primary Outcome Measures

1. Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure) [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.

Secondary Outcome Measures

1. 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) [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.

2. Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. COPE patient between age of 18-30

2. Capacity to give informed consent

3. Currently using a reliable method of birth control (female) (condom plus spermicide, diaphragm plus spermicide, IUD, birth control pills, norplant, vasectomy in partner)

Exclusion Criteria:

1. Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium

2. Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents

3. Lifetime diagnosis of renal failure/disease

4. Acute neurological, neuroendocrine,or medical disorder including renal insufficiency

5. Lifetime diagnosis of hypertension or diabetes

6. Intelligence Quotient (IQ) < 70

7. Acute risk for suicide and/or violence

8. Pregnant, lactating

9. Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)

10. Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also Depakote, lithium, lamotrigine, pregabalin or any med with a mechanism of action like gabapentin)

11. The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Ragy Girgis, M.D., NYSPI/Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scott Small, Professor of Neurology, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02557945
• Other Study ID Numbers: 7165R
• First Posted: Sep 23, 2015
• Last Update Posted: May 3, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Psychotic Disorders; Mental Disorders; Gabapentin

Study Results

Participant Flow

Recruitment Details	9 individuals signed consent and underwent screening procedures for the study. 6 of the 9 were randomized to receive gabapentin/placebo

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	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)	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)
Period Title: Overall Study
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Gabapentin	Placebo	Total
Arm/Group Description	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)	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 of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	3 100%	6 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	1 33.3%	1 16.7%
Male	3 100%	2 66.7%	5 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	3 100%	3 100%	6 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 66.7%	2 66.7%	4 66.7%
White	1 33.3%	1 33.3%	2 33.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
Description	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

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	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)	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)
Measure Participants	2	3
Mean (Standard Error) [percent change]	-0.005 (0.388)	0.38 (0.317)

2. Secondary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

For general symptom score (G score) and disorganization symptom (D score), 1 participant had missing data and was not included in the data reporting.

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	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)	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)
Measure Participants	2	3
P score change	-1.5	0.66
N score change	-1	-1.66
G score change	-1.5	0.5
D score change	2	-2.5

3. Secondary Outcome

Title	Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	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)	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)
Measure Participants	2	3
Mean (Full Range) [Change in raw learning slope]	0.1	-0.3

Adverse Events

Time Frame	From consent to completion of participation (approximately 42 days)
Arm/Group Title	Gabapentin		Placebo
Arm/Group Description	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)		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)
All Cause Mortality
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Serious Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		0/3 (0%)
Nervous system disorders
paresthesias	1/3 (33.3%)	1	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.