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Gabapentin in Patients at Clinical Risk for Psychosis

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ClinicalTrials.gov Identifier: NCT02557945
Recruitment Status : Suspended (This study is temporarily suspended due to COVID-19)
First Posted : September 23, 2015
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Scott Small, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 31, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE August 1, 2015
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
Change in Left CA1 Cerebral Blood Volume (CBV) (MRI measure) [ Time Frame: 6 weeks ]
Change in left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
Change in Left CA1 CBV (MRI measure) [ Time Frame: 6 weeks ]
Change in left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
  • 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
  • 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 (e.g., Learning slope)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • Change in positive, negative, disorganization, and general symptoms over time as measured by the SIPS/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
  • Change in cognitive function (hippocampal-dependent verbal memory) as measured by the CVLT [ Time Frame: 6 weeks ]
    Exploratory analyses will be conducted on changes between gabapentin and placebo groups on CVLT measures (e.g., Learning slope)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gabapentin in Patients at Clinical Risk for Psychosis
Official Title  ICMJE Gabapentin in Patients at Clinical Risk for Psychosis
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Clinical High Risk for Psychosis
Intervention  ICMJE
  • Drug: Gabapentin
    Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
  • Drug: Placebo
    Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Study Arms  ICMJE
  • Experimental: Gabapentin
    Gabapentin 3600mg PO daily
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Matching placebo PO daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, vasctomy 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557945
Other Study ID Numbers  ICMJE 7165R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Small, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ragy Girgis, M.D. NYSPI/Columbia
PRS Account New York State Psychiatric Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP