Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322023
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2006-05-02
Brief Title:
Safety and Effectiveness of D-serine in Schizophrenia
Sponsor:
Nathan Kline Institute for Psychiatric Research
Organization:
Nathan Kline Institute for Psychiatric Research
Study Overview
Official Title:
PKPD Study of Escalating Dose D-serine as Adjunctive Treatment in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia
Detailed Description:
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year Schizophrenia can be extremely disabling causing people to hear voices experience paranoia or hallucinations believe that others are controlling their thoughts and even fail at maintaining a job or caring for themselves Current medications help to relieve most of these symptoms but not all Some people with schizophrenia still suffer from negative symptoms such as difficulty with talking expressing emotions and motivation they may also suffer from cognitive impairments such as decreased concentration and memory loss D-serine an amino acid found within the body activates brain cell receptors that appear to play a role in learning and memory This study will determine whether adding a D-serine solution to a stable antipsychotic medication regimen will decrease negative symptoms in people with schizophrenia
Participants in this open-label study will remain on their regular medication regimen for at least 2 weeks During this time and before starting treatment participants will be interviewed about their emotional problems marital status education family background employment history and any drug or alcohol problems Participants will also undergo a physical exam an electrocardiogram EKG vital sign measurements psychological tests cognitive tasks and an electroencephalogram EEG Participants will then begin 4 weeks of treatment with D-serine In addition to participants regular medication regimen they will drink a D-serine powder mixed with water twice daily Every 2 weeks participants will undergo a physical exam and an interview about any changes in symptoms or emotional problems that they may be experiencing Blood and urine samples will be taken throughout the study After 4 weeks participants will undergo an EKG EEG and the same psychological tests and cognitive tasks completed prior to treatment A follow-up visit will occur 2 weeks post-treatment to monitor any changes in negative symptoms
Participants in this open-label study will remain on their regular medication regimen for at least 2 weeks During this time and before starting treatment participants will be interviewed about their emotional problems marital status education family background employment history and any drug or alcohol problems Participants will also undergo a physical exam an electrocardiogram EKG vital sign measurements psychological tests cognitive tasks and an electroencephalogram EEG Participants will then begin 4 weeks of treatment with D-serine In addition to participants regular medication regimen they will drink a D-serine powder mixed with water twice daily Every 2 weeks participants will undergo a physical exam and an interview about any changes in symptoms or emotional problems that they may be experiencing Blood and urine samples will be taken throughout the study After 4 weeks participants will undergo an EKG EEG and the same psychological tests and cognitive tasks completed prior to treatment A follow-up visit will occur 2 weeks post-treatment to monitor any changes in negative symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A5-EPTD | US NIH GrantContract | None | httpsreporternihgovquickSearchU01MH074356 |
| U01MH074356 | NIH | None | None |