StressPhase 1CXB722-100NCT00814931
Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males
A Phase 1 study testing CXB722 in people with Stress and Anxiety, run by CeNeRx BioPharma Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress response and subjective reports related to mood and stress during and after experimentally induced stress among healthy young males. Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- What is being tested?
- CXB722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2008
- 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 18 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18 to 34 years of age, inclusive, at screening
- Able to read, understand and converse in English
- Able to read, understand, and provide written, dated informed consent
- Willing to refrain from the use of any concomitant medications (including over-the counter (OTC)) and nutritional/herbal supplements and comply with all study requirements
- Willing to submit to daily breathalyzer testing each day study medication is administered over the course of the study
- In good general health as ascertained by medical history, physical examination (PE) including measurement of vital signs, clinical laboratory evaluations, and 12-lead electrocardiogram (ECG)
Who cannot join
- Evidence on physical examination or laboratory findings of chronic liver or renal disease or other chronic physical disorders
- Evidence of cardiovascular disease on 12 lead ECG, vital signs or laboratory findings
- Significant anxiety as indicated by a score of 47 or higher on the "Trait" score of Spielberger State-Trait Anxiety Scale
- Family history (first degree relative) of hypertension or cardiovascular disease prior to age 40
- Evidence on physical or laboratory examination of endocrinopathies or immunopathies, including HIV
- BMI of 30 or greater, evidence of significant recent weight change or history of obesity
Show all 16Show fewer
- History of any psychiatric disorder, or evidence of such a disorder based on a psychiatric evaluation which includes the Structured Clinical Interview for DSM-IV-TR (SCID)
- History of any physical condition which, in the investigator's opinion, might put the participant at risk or interfere with the interpretation of study results
- Use of any prescription or over-the-counter (OTC) medications (including herbal remedies) within 14 days of study randomization
- Use of tobacco products or any nicotine-containing products (e.g., gum, patch) within the past 6 months (prior to screening)
- Positive screening urine test for nicotine or drugs of abuse: cannabinoids, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, or alcohol in the blood
- Unwillingness to agree to avoid strenuous activity over the course of the study
- Poor likelihood, in the investigator's judgment, of full cooperation during the study and/or poor compliance is anticipated
- Previously screened for this trial
- Consumes more than four cups of coffee daily
- Deviates from normal nocturnal sleeping patterns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Multiple Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Examining the Effects of CXB722 in Mitigating Neuroendocrine Stress Response in Healthy Males
The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress response and subjective reports related to mood and stress during and after experimentally induced stress among healthy young males.
Read the detailed description
Acute stress produces a cascade of physiological and psychological effects, including increased cardiovascular function, increases in circulating levels of stress hormones and neurotransmitter levels, and changes in mood and subjective state. The Trier Social Stress Test (TSST) is a standardized, well-validated procedure that was developed in order to provide a controlled method for exposing subjects to a stressor. The TSST consists of a public speaking and a mental arithmetic test performed in the context of a mock job interview.
A drug that could safely block or mitigate the stress response would have multiple applications in medicine, beyond treating anxiety, because stress is associated with many disease states, including cardiovascular disease. The drug being studied, CXB722, is thought to show promise in diminishing the physiologic and psychological effects of stress.
- Being tested
- CXB722, Placebo
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXB722Drug
Also called Pivagabine
900 mg CXB722 oral liquid suspension twice a day for 8 days
PlaceboDrug
matching oral liquid suspension placebo twice a day for 8 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Group Receives: Drug: CXB722 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma cortisol and salivary cortisol levels
Measured: Screening and Study Day 8
Secondary outcomes (7)
Plasma ACTH
Measured: Screening and Study Day 8
Plasma epinephrine and norepinephrine
Measured: Screening and Study Day 8
Profile of Mood States (POMS) Tension-Anxiety
Measured: Screening and Study Day 8
Fatigue-Inertia, and Vigor-Activity factor scores
Measured: Screening and Study Day 8
"State" score on the Spielberger State-Trait Anxiety Scale (SSTAS)
Measured: Screening and Study Day 8
Seven Visual Analog Scales (VAS)
Measured: Screening and Study Day 8
HR, and systolic and diastolic BP
Measured: Screening and Study Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeNeRx BioPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlos Santana, MD, Principal investigator, USF Physicians Group, Associate Professor, Director of Adult Outpatient Services, Department of Psychiatry and Behavioral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814931
- Sponsor's protocol ID
- AG0114
- Acronym
- CXB722-100
- Status last verified
- Jan 2009
- First submitted
- 23 Dec 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
PubMed 8255414Kirschbaum C, Strasburger CJ, Langkrar J. Attenuated cortisol response to psychological stress but not to CRH or ergometry in young habitual smokers. Pharmacol Biochem Behav. 1993 Mar;44(3):527-31. doi: 10.1016/0091-3057(93)90162-m.
PubMed 8451256
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Examining the Effects of CXB722 in Mitigating Neuroendocrine Stress Response in Healthy Males
- ClinicalTrials.gov ID
- NCT00814931
- Acronym / sponsor ID
- CXB722-100 / AG0114
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CeNeRx BioPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Dec 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.
The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress response and subjective reports related to mood and stress during and after experimentally induced stress among healthy young males.
Detailed description
Acute stress produces a cascade of physiological and psychological effects, including increased cardiovascular function, increases in circulating levels of stress hormones and neurotransmitter levels, and changes in mood and subjective state. The Trier Social Stress Test (TSST) is a standardized, well-validated procedure that was developed in order to provide a controlled method for exposing subjects to a stressor. The TSST consists of a public speaking and a mental arithmetic test performed in the context of a mock job interview.
A drug that could safely block or mitigate the stress response would have multiple applications in medicine, beyond treating anxiety, because stress is associated with many disease states, including cardiovascular disease. The drug being studied, CXB722, is thought to show promise in diminishing the physiologic and psychological effects of stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CXB722Treatment Group |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male, 18 to 34 years of age, inclusive, at screening
- Able to read, understand and converse in English
- Able to read, understand, and provide written, dated informed consent
- Willing to refrain from the use of any concomitant medications (including over-the counter (OTC)) and nutritional/herbal supplements and comply with all study requirements
- Willing to submit to daily breathalyzer testing each day study medication is administered over the course of the study
Key exclusion criteria (16 listed)
- Evidence on physical examination or laboratory findings of chronic liver or renal disease or other chronic physical disorders
- Evidence of cardiovascular disease on 12 lead ECG, vital signs or laboratory findings
- Significant anxiety as indicated by a score of 47 or higher on the "Trait" score of Spielberger State-Trait Anxiety Scale
- Family history (first degree relative) of hypertension or cardiovascular disease prior to age 40
- Evidence on physical or laboratory examination of endocrinopathies or immunopathies, including HIV
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 |
|---|---|---|
| CXB722Also: Pivagabine900 mg CXB722 oral liquid suspension twice a day for 8 days | Drug | 1 |
| Placebomatching oral liquid suspension placebo twice a day for 8 days | Drug | 2 |
Primary outcome
Plasma cortisol and salivary cortisol levels
Time frame: Screening and Study Day 8
7 secondary outcomes
Plasma ACTH
Time frame: Screening and Study Day 8
Plasma epinephrine and norepinephrine
Time frame: Screening and Study Day 8
Profile of Mood States (POMS) Tension-Anxiety
Time frame: Screening and Study Day 8
Fatigue-Inertia, and Vigor-Activity factor scores
Time frame: Screening and Study Day 8
"State" score on the Spielberger State-Trait Anxiety Scale (SSTAS)
Time frame: Screening and Study Day 8
Seven Visual Analog Scales (VAS)
Time frame: Screening and Study Day 8
HR, and systolic and diastolic BP
Time frame: Screening and Study Day 8
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 13 Jan 2009.
- Background: PubMed 8255414Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
- Background: PubMed 8451256Kirschbaum C, Strasburger CJ, Langkrar J. Attenuated cortisol response to psychological stress but not to CRH or ergometry in young habitual smokers. Pharmacol Biochem Behav. 1993 Mar;44(3):527-31. doi: 10.1016/0091-3057(93)90162-m.
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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.
Carlos Santana, MD principal investigator
USF Physicians Group, Associate Professor, Director of Adult Outpatient Services, Department of Psychiatry and Behavioral Medicine
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 CXB722 in people with Stress and Anxiety, run by CeNeRx BioPharma Inc. 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 6 inclusion and 16 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 13 Jan 2009. 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?
Plasma cortisol and salivary cortisol levels (time frame: Screening and Study Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814931, which also lists 2 linked publications.
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 13 Jan 2009.