SchizophreniaNCT00197483
Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia
An observational study of Schizophrenia and Negative Symptoms, run by Hamamatsu University at 1 site in Japan.
Trial summary
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Negative Symptoms, Cognitive Impairments
- What is being tested?
- Pergolide (drug)
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2003to not given
- Phase
- Observational
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients
- Were age 18-50 years, met the DSM-IV criteria for schizophrenia
- Were treated with a stable dose of risperidone, raging 2 to 6mg, for more than 8 weeks
- Had a score ≥15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS)
- Had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks
Who cannot join
- Had a history of medical condition or drug treatment that may have affected cognitive performance
- Had a history of other psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. This double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.
- Conditions
- Schizophrenia, Negative Symptoms, Cognitive Impairments
- Being tested
- Pergolide (drug)
- Keywords
- Pergolide, Dopamine D1, Schizophrenia, Cognitive disturbance, Negative symptoms
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pergolide (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Investigators
- Norio Mori, Ph.D, Study chair, Hamamatsu University, School of Medicine, Department of Psychiatry and Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197483
- Sponsor's protocol ID
- 01T-080
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Publications
Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7. doi: 10.1016/s0028-3932(02)00317-2.
PubMed 12667537Muller U, von Cramon DY, Pollmann S. D1- versus D2-receptor modulation of visuospatial working memory in humans. J Neurosci. 1998 Apr 1;18(7):2720-8. doi: 10.1523/JNEUROSCI.18-07-02720.1998.
PubMed 9502829Wang M, Vijayraghavan S, Goldman-Rakic PS. Selective D2 receptor actions on the functional circuitry of working memory. Science. 2004 Feb 6;303(5659):853-6. doi: 10.1126/science.1091162.
PubMed 14764884Goldman-Rakic PS, Castner SA, Svensson TH, Siever LJ, Williams GV. Targeting the dopamine D1 receptor in schizophrenia: insights for cognitive dysfunction. Psychopharmacology (Berl). 2004 Jun;174(1):3-16. doi: 10.1007/s00213-004-1793-y. Epub 2004 Apr 30.
PubMed 15118803
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia
- ClinicalTrials.gov ID
- NCT00197483
- Acronym / sponsor ID
- 01T-080
- Conditions
- Schizophrenia, Negative Symptoms, Cognitive Impairments
- Keywords
- Pergolide, Dopamine D1, Schizophrenia, Cognitive disturbance, Negative symptoms
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 20 participants
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Mar 2003
- First posted
- 20 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.
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. This double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients
- Were age 18-50 years, met the DSM-IV criteria for schizophrenia
- Were treated with a stable dose of risperidone, raging 2 to 6mg, for more than 8 weeks
- Had a score ≥15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS)
- Had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks
Key exclusion criteria (2 listed)
- Had a history of medical condition or drug treatment that may have affected cognitive performance
- Had a history of other psychiatric disorders
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 |
|---|---|---|
| Pergolide (drug) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
- Background: PubMed 12667537Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7. doi: 10.1016/s0028-3932(02)00317-2.
- Background: PubMed 9502829Muller U, von Cramon DY, Pollmann S. D1- versus D2-receptor modulation of visuospatial working memory in humans. J Neurosci. 1998 Apr 1;18(7):2720-8. doi: 10.1523/JNEUROSCI.18-07-02720.1998.
- Background: PubMed 14764884Wang M, Vijayraghavan S, Goldman-Rakic PS. Selective D2 receptor actions on the functional circuitry of working memory. Science. 2004 Feb 6;303(5659):853-6. doi: 10.1126/science.1091162.
- Background: PubMed 15118803Goldman-Rakic PS, Castner SA, Svensson TH, Siever LJ, Williams GV. Targeting the dopamine D1 receptor in schizophrenia: insights for cognitive dysfunction. Psychopharmacology (Berl). 2004 Jun;174(1):3-16. doi: 10.1007/s00213-004-1793-y. Epub 2004 Apr 30.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Norio Mori, Ph.D study chair
Hamamatsu University, School of Medicine, Department of Psychiatry and Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Negative Symptoms, run by Hamamatsu University at 1 site in Japan.
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 2 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: paused, as of the sponsor's last update on 20 Sep 2005. 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 Japan. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197483, which also lists 4 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 20 Sep 2005.