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Gabapentin in Patients at Clinical Risk for Psychosis

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ClinicalTrials.gov Identifier: NCT02557945
Recruitment Status : Unknown
Verified December 2016 by New York State Psychiatric Institute.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Gabapentin in Patients at Clinical Risk for Psychosis
Study Start Date : August 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


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) [ 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

  2. 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)



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557945


Contacts
Contact: Gary Brucato, PhD 646-774-5232

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Gary Brucato, PhD    646-774-5232    gb2428@columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Ragy Girgis, M.D. NYSPI/Columbia

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02557945     History of Changes
Other Study ID Numbers: 7165R
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents