SchizophreniaNCT01123317
Brain Blood Flow Changes Elicited by Oxytocin in Volunteers With and Without Schizophrenia
A study testing Oxytocin in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to assess how oxytocin delivered intranasally changes regional brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15 labeled water in persons with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2013
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal volunteers: Age range: 18-55 years of age
- Normal Volunteers: No psychiatric illness in self; no psychotic illness in first degree relatives
- Normal Volunteers: No previous history of substance dependence in last 6 months; no substance abuse in last month
- Normal Volunteers: No contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Normal Volunteers: Not pregnant
- Normal Volunteers: No major medical illness (e.g. seizure disorder) or medication that affects brain structure (e.g. steroids)
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- Normal Volunteers: Participation in Healthy Subject Recruitment protocol (HP-00042350).
- Patient Volunteers: DSM-IV diagnosis of schizophrenia
- Patient Volunteers: Voluntary and competent to sign an informed consent
- Patient Volunteers: No contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Patient Volunteers: No previous history of substance dependence in last 6 months; no substance abuse in last month
- Patient Volunteers: Not pregnant
- Patient Volunteers: No major medical illness other than schizophrenia that affects brain structure (e.g. seizure disorder); not currently taking medication other than that for schizophrenia that affects brain structure (e.g. steroids)
- Patient Volunteers: No diagnosis of Major Depressive Disorder within last 6 months
- Patient Volunteers: SANS Asociality global score 2 or greater
- Patient Volunteers: No change in antipsychotic medication (type and dose) within the last 4 weeks
- Patient volunteers: Age range: 18-55 years of age
Who cannot join
- Normal Volunteers: Age outside of specified range -Normal Volunteers: Psychiatric illness in self; psychotic illness in first- degree relative
- Normal Volunteers: Previous history of substance dependence in last 6 months; substance abuse in last month
- Normal Volunteers: Contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Normal Volunteers: Pregnant
- Normal Volunteers: Major medical illness (e.g. seizure disorder) or medication that affects brain structure (e.g. steroids)
- Patient Volunteers: Age outside of specified range
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- Patient Volunteers: Contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Patient Volunteers: History of substance dependence in last 6 months; substance abuse in last month
- Patient Volunteers: Pregnancy
- Patient Volunteers: Major medical illness other than schizophrenia that affects brain structure; currently taking medication other than that for schizophrenia that affects brain structure
- Patient Volunteers: Diagnosis of Major Depressive Disorder within last 6 months
- Patient Volunteers: SANS Asociality global score < 2
- Patient Volunteers: Change in antipsychotic medication (type and dose) within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Official title: Brain Blood Flow Changes Elicited by Oxytocin in Healthy and Schizophrenic Volunteers, an Assessment Using Positron Emission Tomography and 15-Oxygen Labeled Water
The purpose of this study is to assess how oxytocin delivered intranasally changes regional brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15 labeled water in persons with schizophrenia. The objective is to better our understanding of oxytocin's role in the modulation of social judgment in schizophrenia and provide more information as to potential uses of oxytocin or a similar drug analog in treating certain features of schizophrenia and other neuropsychiatric disorders.
Read the detailed description
Schizophrenia is a severely debilitating psychiatric disorder that afflicts approximately 1% of the population (American Psychiatric Association, 1994) and is a serious public health problem. The specific mechanism of schizophrenia remains unknown. Affective responsivity and adaptive social behaviors are fundamental impairments in people with schizophrenia. These features have a detrimental impact on function in many areas of daily life. Unfortunately, the brain mechanisms that underlie these problems are still not understood. This study will use positron emission tomography (PET) and regional cerebral blood flow (rCBF) measures to ascertain the timing (1.5 hour period) of OT action on absolute regional brain activity in schizophrenia (SZ) and healthy control (HC) subjects. Particular focus will be on the amygdala, ventral striatum, anterior hippocampus and hypothalamus (neural regions involved in affliative behavior). Subjects will be studied with intranasally administered oxytocin and placebo while at rest and while making judgments about emotional faces. This approach will tell us to what extent the amygdala and limbic system's physiological response to oxytocin is predictive of a subject's behavioral sensitivity to this neuropeptide. The elucidation of this information may have a significant impact on predicting functional outcome and novel drug treatments in schizophrenia.
Functional magnetic resonance imaging (MRI) studies show that oxytocin modulates the amygdala's response during social and emotional decisions. When administered intranasally, OT may be beneficial for the treatment of negative symptoms in schizophrenia by enhancing a person's affiliative behavior and diminishing distrust. It is not, however, known to what extent intranasal oxytocin modifies regional neurotransmission and human brain metabolism. There are at present no studies in animals or humans specifically examining the time course action of OT on whole brain activity.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin
- Keywords
- Schizophrenia, PET, Oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Subjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Subjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2 Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin induced rCBF changes
Oxytocin induced rCBF changes in the amygdala, ventral striatum, hypothalamus and anterior hippocampus (post-drug versus pre-drug, resting and task conditions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2013 (estimated)
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Buchanan, University of Maryland, Baltimore
- Investigators
- Henry Holcomb, M.D., Principal investigator, MPRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123317
- Sponsor's protocol ID
- HP-00041288
- Status last verified
- Aug 2019
- First submitted
- 12 May 2010
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Blood Flow Changes Elicited by Oxytocin in Healthy and Schizophrenic Volunteers, an Assessment Using Positron Emission Tomography and 15-Oxygen Labeled Water
- ClinicalTrials.gov ID
- NCT01123317
- Acronym / sponsor ID
- HP-00041288
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, PET, Oxytocin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 14 May 2010 (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.
The purpose of this study is to assess how oxytocin delivered intranasally changes regional brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15 labeled water in persons with schizophrenia. The objective is to better our understanding of oxytocin's role in the modulation of social judgment in schizophrenia and provide more information as to potential uses of oxytocin or a similar drug analog in treating certain features of schizophrenia and other neuropsychiatric disorders.
Detailed description
Schizophrenia is a severely debilitating psychiatric disorder that afflicts approximately 1% of the population (American Psychiatric Association, 1994) and is a serious public health problem. The specific mechanism of schizophrenia remains unknown. Affective responsivity and adaptive social behaviors are fundamental impairments in people with schizophrenia. These features have a detrimental impact on function in many areas of daily life. Unfortunately, the brain mechanisms that underlie these problems are still not understood. This study will use positron emission tomography (PET) and regional cerebral blood flow (rCBF) measures to ascertain the timing (1.5 hour period) of OT action on absolute regional brain activity in schizophrenia (SZ) and healthy control (HC) subjects. Particular focus will be on the amygdala, ventral striatum, anterior hippocampus and hypothalamus (neural regions involved in affliative behavior). Subjects will be studied with intranasally administered oxytocin and placebo while at rest and while making judgments about emotional faces. This approach will tell us to what extent the amygdala and limbic system's physiological response to oxytocin is predictive of a subject's behavioral sensitivity to this neuropeptide. The elucidation of this information may have a significant impact on predicting functional outcome and novel drug treatments in schizophrenia.
Functional magnetic resonance imaging (MRI) studies show that oxytocin modulates the amygdala's response during social and emotional decisions. When administered intranasally, OT may be beneficial for the treatment of negative symptoms in schizophrenia by enhancing a person's affiliative behavior and diminishing distrust. It is not, however, known to what extent intranasal oxytocin modifies regional neurotransmission and human brain metabolism. There are at present no studies in animals or humans specifically examining the time course action of OT on whole brain activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinSubjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Normal volunteers: Age range: 18-55 years of age
- Normal Volunteers: No psychiatric illness in self; no psychotic illness in first degree relatives
- Normal Volunteers: No previous history of substance dependence in last 6 months; no substance abuse in last month
- Normal Volunteers: No contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Normal Volunteers: Not pregnant
Key exclusion criteria (13 listed)
- Normal Volunteers: Age outside of specified range -Normal Volunteers: Psychiatric illness in self; psychotic illness in first- degree relative
- Normal Volunteers: Previous history of substance dependence in last 6 months; substance abuse in last month
- Normal Volunteers: Contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
- Normal Volunteers: Pregnant
- Normal Volunteers: Major medical illness (e.g. seizure disorder) or medication that affects brain structure (e.g. steroids)
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 |
|---|---|---|
| OxytocinAlso: SyntocinonSubjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2 | Drug | Oxytocin |
Primary outcome
Oxytocin induced rCBF changes
Time frame: 2 years
Oxytocin induced rCBF changes in the amygdala, ventral striatum, hypothalamus and anterior hippocampus (post-drug versus pre-drug, resting and task conditions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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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.
Henry Holcomb, M.D. principal investigator
MPRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Schizophrenia, run by University of Maryland, Baltimore 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 17 inclusion and 13 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: withdrawn, as of the sponsor's last update on 19 Aug 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Oxytocin induced rCBF changes (time frame: 2 years). 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 19 Aug 2019.