Gabapentin in Patients at Clinical Risk for Psychosis

NCT ID: NCT02557945

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2016-06-12

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.

Conditions

Clinical High Risk for Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Gabapentin

Gabapentin 3600mg PO daily

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

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

Placebo

Matching placebo PO daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Gabapentin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Scott Small

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragy Girgis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYSPI/Columbia

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

7165R

Identifier Type: -

Identifier Source: org_study_id