Cognitive DysfunctionPhase 1NCT00611572
GABA-glutamate Interactions and Psychosis
A Phase 1 study testing iomazenil in people with Cognitive Dysfunction, run by Yale University at 1 site in United States.
Trial summary
This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- iomazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 2 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages of 21-45 years from all ethnic backgrounds.
- Male or female.
- Written informed consent.
Who cannot join
- DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
- History of abnormal EEG.
- History of severe allergies or multiple adverse drug reactions.
- Any medication that could interfere with either the safety of the study and/or the outcome measures.
- Any other conditions which in the opinion of the investigator would preclude participation in the study.
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- History of major psychiatric disorder in first degree relatives.
- Current substance abuse/dependency determined by urine toxicology.
- Treatment with medications with CNS effects.
- Treatment with benzodiazepines within one week prior to testing.
- Current treatment with medications with psychotropic effects.
- Education < 10th grade.
- IQ < 70, MR.
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.
- Conditions
- Cognitive Dysfunction
- Being tested
- iomazenil
- Keywords
- GABA, glutamate, NMDA, P300, MMN
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iomazenilDrug
Given as IV infusion
iomazenilDrug
saline IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active iomazenil and ketamine Receives: Drug: iomazenil |
| 2 | Placebo comparator | placebo iomazenil and ketamine Receives: Drug: iomazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
P300 as an ERP measure
Measured: prospective
Secondary outcomes (1)
MMN (Mismatch Negativity)
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJan 2007
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Mohini Ranganathan, M.D., Principal investigator, Yale School of Medicine, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611572
- Sponsor's protocol ID
- 0508000517
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2008
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT00611572
- Acronym / sponsor ID
- 0508000517
- Conditions
- Cognitive Dysfunction
- Keywords
- GABA, glutamate, NMDA, P300, MMN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jan 2007
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: iomazenilActive iomazenil and ketamine |
| 2 | Placebo comparator | Drug: iomazenilplacebo iomazenil and ketamine |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages of 21-45 years from all ethnic backgrounds.
- Male or female.
- Written informed consent.
Key exclusion criteria (14 listed)
- DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
- History of abnormal EEG.
- History of severe allergies or multiple adverse drug reactions.
- Any medication that could interfere with either the safety of the study and/or the outcome measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iomazenilGiven as IV infusion | Drug | 1 |
| iomazenilsaline IV infusion | Drug | 2 |
Primary outcome
P300 as an ERP measure
Time frame: prospective
1 secondary outcome
MMN (Mismatch Negativity)
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohini Ranganathan, M.D. principal investigator
Yale School of Medicine, Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iomazenil in people with Cognitive Dysfunction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P300 as an ERP measure (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.