NCT02557945

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2016

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

August 31, 2015

Results QC Date

March 4, 2022

Last Update Submit

April 30, 2022

Conditions

Clinical High Risk for Psychosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (2)

  • 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

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

    6 weeks

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 3600mg PO daily

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Matching placebo PO daily

Drug: Placebo

Interventions

GabapentinDRUG

Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)

Gabapentin
PlaceboDRUG

Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Scott Small, MD
Organization
New York State Psychiatric Institute
sas68@cumc.columbia.edu
212-305-1269

Study Officials

  • Ragy Girgis, M.D.

    NYSPI/Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 23, 2015

Study Start

August 1, 2015

Primary Completion

June 12, 2016

Study Completion

June 12, 2016

Last Updated

May 3, 2022

Results First Posted

May 3, 2022

Record last verified: 2022-04

Locations

US(1)