Gabapentin in Patients at Clinical Risk for Psychosis

New York State Psychiatric Institute

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Clinical High Risk for Psychosis

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02557945

7165R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin 3600mg PO daily

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Matching placebo PO daily

Treatment:

Drug: Placebo