Gabapentin in Patients at Clinical Risk for Psychosis

• Status: Suspended
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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