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Gabapentin in Patients at Clinical Risk for Psychosis

Primary Purpose

Clinical High Risk for Psychosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Clinical High Risk for Psychosis

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

Gabapentin 3600mg PO daily

Matching placebo PO daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 31, 2015
Last Updated
April 30, 2022
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02557945
Brief Title
Gabapentin in Patients at Clinical Risk for Psychosis
Official Title
Gabapentin in Patients at Clinical Risk for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Combination of insufficient funding and lack of compelling findings
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
June 12, 2016 (Actual)
Study Completion Date
June 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Psychosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin 3600mg PO daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo PO daily
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPE patient between age of 18-30 Capacity to give informed consent 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: Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents Lifetime diagnosis of renal failure/disease Acute neurological, neuroendocrine,or medical disorder including renal insufficiency Lifetime diagnosis of hypertension or diabetes Intelligence Quotient (IQ) < 70 Acute risk for suicide and/or violence Pregnant, lactating Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics) 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) The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragy Girgis, M.D.
Organizational Affiliation
NYSPI/Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Gabapentin in Patients at Clinical Risk for Psychosis

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