Gabapentin in Patients at Clinical Risk for Psychosis

Clinical High Risk for Psychosis Clinical Trial

Official title:

Gabapentin in Patients at Clinical Risk for Psychosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02557945
• Other study ID #: 7165R
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 1, 2015
• Est. completion date: June 12, 2016

Study information

• Verified date: April 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 12, 2016
• Est. primary completion date: June 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score at baseline indicates less symptoms, and therefore a negative change over the 6 week period indicates an improvement, and a positive change indicates worsening of symptoms.	6 weeks
Secondary	Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)	Exploratory analyses will be conducted on changes between gabapentin and placebo groups on the California Verbal Learning Test-Second Edition (CLVT-II) measures. The unit measured was 'learning slope', where higher slope indicates better memory and a lower slope indicates poorer memory.	6 weeks