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SchizophreniaPhase 1NCT00364429

SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia

A Phase 1 study testing [123]I-CNS 1261, Lorazepam and Risperidone in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is also relevant.Fifteen healthy subjects (male… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
[123]I-CNS 1261, Lorazepam and Risperidone
How many people
55 participants
Where
1 siteSpain
Study dates
Jul 2005to Jul 2005
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Right-handed
  • Smoker
  • Healthy volunteer or schizophrenic patients as diagnosed by DSM IV criteria.
  • Treatment naive patients or with Risperidone treatment for 2 months that have not received any depot neuroleptic during the last year.
  • Women of childbearing potential must agree to acceptable method of birth control.

Who cannot join

  • Any clinically or laboratory significant abnormality.
  • Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
  • Heart pacemaker, metallic prosthesis or other metallic body implants.
  • History or presence of CNS conditions.
  • History of substance dependence.
  • History of or suffers from claustrophobia.
  • Positive test for HBV (hepatitis B virus), HCV (hepatitis C virus) or HIV.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • GSK Investigational Site

    Barcelona

Other trials in Spain

About this study

Official title: Investigation of the NMDA Receptor System in Man as a Potential Surrogate Marker for Deficit Syndrome in Schizophrenia: a [123]I-CNS 1261 Single Photon Emission Tomography (SPET) Study

This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before: Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).

Conditions
Schizophrenia
Being tested
[123]I-CNS 1261, Lorazepam, Risperidone
Keywords
schizophrenic patients, SPET, NMDA receptor, ligand [123]I-CNS 1261
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [123]I-CNS 1261Drug

    Study Drug

  • LorazepamDrug

    Study Drug

  • RisperidoneDrug

    Also called [123]I-CNS 1261, Lorazepam

    Study Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients.

    Measured: throughout the study

Secondary outcomes (1)

  1. Effect of treatment with risperidone and lorazepam in inducing changes on [123]I CNS 1261 binding, and its relationship with the plasma concentration of administered drugs and with Psychopathological scales scores.

    Measured: throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2005
  4. Study completionJul 2005

Why it stopped: terminated

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00364429
Sponsor's protocol ID
102747
Status last verified
Jan 2016
First submitted
11 Aug 2006
Last updated
11 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [123]I-CNS 1261, Lorazepam and Risperidone in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Spain.

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 5 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: stopped early, as of the sponsor's last update on 11 Jan 2016. 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 Spain. 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.

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 was stopped early (reason given: terminated). Results are not available in the source record.

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?

CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients. (time frame: throughout the study). 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 NCT00364429.

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 11 Jan 2016.

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