SchizophreniaNCT00206986
Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?
A study testing clonidine in people with Schizophrenia, run by Birte Glenthoj at 1 site in Denmark.
Trial summary
The investigators want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- May 2005to Dec 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- Male subjects
- Meeting the DSM-IV diagnosis of schizophrenia
- Controls:
- Male subjects
- Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist
- Non smokers
Who cannot join
- Patients:
- A P50 suppression or PPI score falling within a range of 10 percent above or below the mean score of the healthy control group
- Controls:
- Current use of any medication
- Any subject who has received any investigational medication within 30 days prior to the start of this study
- History of neurologic illness
- History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
- History of alcohol and drug abuse.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Copenhagen NV, DK-2400
About this study
The investigators want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia.
Read the detailed description
A number of reports in literature provide evidence for, among others, an increased central noradrenergic activity in schizophrenia. In addition to this increased noradrenergic activity, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle reflex (PPI). In two separate initial studies in our laboratory, we found reduced sensory gating following administration of imipramine (a combined noradrenergic and serotonergic agonist) and desipramine (a highly specific noradrenergic agonist) to healthy volunteers. This provides evidence for a direct causal relation between the increased noradrenergic activity and the disturbed gating of sensory information, as both commonly found in patients with schizophrenia. Therefore, in a follow-up study, the effects of a noradrenergic antagonist will be investigated on the sensory gating of patients with schizophrenia. To further extend the data of our initial studies, the patients will additionally be tested for two psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will conform to a double blind, placebo controlled experiment, in which either four doses (0.25 ug, 50 ug, 75 ug or 150 ug)of clonidine or placebo will be added to the current medical treatment of 20 male patients with schizophrenia on five occasions, separated by at least a week, after which they are tested in the Copenhagen Psychophysiological Test Battery (CPTB).In order to test the effects of clonidine in healthy volunteers, 20 healthy males will receive a fixed dose of 0.15 mg clonidine or placebo on two separate occasions separated by at least a week, after which they will be tested in the CPTB as well.
- Conditions
- Schizophrenia
- Being tested
- clonidine
- Keywords
- Schizophrenia, Information processing, PPI, P50 gating, P300, mismatch negativity, clonidine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
Also called Catapressan
Either placebo or 25 ug, 50 uG 75 ug or 150 ug of clonidine will be added to the current medication of patients with schizophrenia, who are stable on their current medication
clonidineDrug
Also called Catapressan
0.15 mg of clonidine will be administered to 20 healthy male volunteers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: clonidine |
| 2 | Experimental | Not described Receives: Drug: clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following psychophysiological measures:
Measured: prospective
Prepulse Inhibition og the Startle Response (PPI)
Measured: Once, 3.5 hrs after intake of capsule
P50 suppression
Measured: Once, 3.5 hrs after intake of capsule
P300 Event Related Potential
Measured: Once, 3.5 hrs after intake of capsule
Mismatch negativity
Measured: Once, 3.5 hrs after intake of capsule
PANSS
Measured: 5 times hourly after intake of capsule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birte Glenthoj
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Lundbeck Foundation, Glostrup University Hospital, Copenhagen
- Responsible party
- Sponsor-investigator, Birte Glenthoj, University of Copenhagen
- Investigators
- Birte Glenthoj, MD, DMSc., Study director, Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206986
- Sponsor's protocol ID
- 363037-2
- Other IDs
- KF 11-261729
- Status last verified
- Dec 2013
- First submitted
- 12 Sep 2005
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?
- ClinicalTrials.gov ID
- NCT00206986
- Acronym / sponsor ID
- 363037-2
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Information processing, PPI, P50 gating, P300, mismatch negativity, clonidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Birte GlenthojUniversity, hospital or other
- Collaborators
- University of Copenhagen, Lundbeck Foundation, Glostrup University Hospital, Copenhagen
- Study start
- May 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Sep 2005 (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 investigators want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia.
Detailed description
A number of reports in literature provide evidence for, among others, an increased central noradrenergic activity in schizophrenia. In addition to this increased noradrenergic activity, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle reflex (PPI). In two separate initial studies in our laboratory, we found reduced sensory gating following administration of imipramine (a combined noradrenergic and serotonergic agonist) and desipramine (a highly specific noradrenergic agonist) to healthy volunteers. This provides evidence for a direct causal relation between the increased noradrenergic activity and the disturbed gating of sensory information, as both commonly found in patients with schizophrenia. Therefore, in a follow-up study, the effects of a noradrenergic antagonist will be investigated on the sensory gating of patients with schizophrenia. To further extend the data of our initial studies, the patients will additionally be tested for two psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will conform to a double blind, placebo controlled experiment, in which either four doses (0.25 ug, 50 ug, 75 ug or 150 ug)of clonidine or placebo will be added to the current medical treatment of 20 male patients with schizophrenia on five occasions, separated by at least a week, after which they are tested in the Copenhagen Psychophysiological Test Battery (CPTB).In order to test the effects of clonidine in healthy volunteers, 20 healthy males will receive a fixed dose of 0.15 mg clonidine or placebo on two separate occasions separated by at least a week, after which they will be tested in the CPTB as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clonidine |
| 2 | Experimental | Drug: clonidine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients:
- Controls:
Key exclusion criteria (8 listed)
- Patients:
- Controls:
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 |
|---|---|---|
| clonidineAlso: CatapressanEither placebo or 25 ug, 50 uG 75 ug or 150 ug of clonidine will be added to the current medication of patients with schizophrenia, who are stable on their current medication | Drug | 1 |
| clonidineAlso: Catapressan0.15 mg of clonidine will be administered to 20 healthy male volunteers | Drug | 2 |
Primary outcome
The following psychophysiological measures:
Time frame: prospective
Prepulse Inhibition og the Startle Response (PPI)
Time frame: Once, 3.5 hrs after intake of capsule
P50 suppression
Time frame: Once, 3.5 hrs after intake of capsule
P300 Event Related Potential
Time frame: Once, 3.5 hrs after intake of capsule
Mismatch negativity
Time frame: Once, 3.5 hrs after intake of capsule
PANSS
Time frame: 5 times hourly after intake of capsule
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 20 Dec 2013.
- Center for Neuropsychiatric Schizophrenia Research (CNSR)Link provided by the sponsor.
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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.
Birte Glenthoj, MD, DMSc. study director
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clonidine in people with Schizophrenia, run by Birte Glenthoj at 1 site in Denmark.
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 7 inclusion and 8 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 20 Dec 2013. 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 Denmark. 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 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?
The following psychophysiological measures: (time frame: prospective). The study lists 6 primary outcomes in all. 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 20 Dec 2013.