SchizophreniaPhase 3NCT00315081
Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine
A Phase 3 study testing Bromocriptin in people with Schizophrenia and Hyperprolactinemia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Schizophrenia, Hyperprolactinemia
- What is being tested?
- Bromocriptin
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to May 2008
- Phase
- Phase 3
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Female and male schizophrenic patients.
- Antipsychotic treatment with risperidone.
- Diagnosis of a clinically relevant hyperprolactinemia.
- No indication of disturbance of the somato-, cortico or thyreotropic hypophysis-axis (IGF-1, cortisol, ACTH, TSH, FT3, FT4)
Who cannot join
- Severe somatic disease, especially coronary disease.
- Acute psychotic exacerbation.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Bonn, Department of Psychiatry
Bonn, Northrhine-Westfalia, 53105
Kai-Uwe Kuehn, MD, 0049-(0)2228-287-5681, kai-uwe.kuehn@ukb.uni-bonn.de
About this study
Official title: Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones.
Read the detailed description
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have been successfully medicated for years with dopamine agonists like bromocriptine.
In patients with psychiatric diseases hyperprolactinemia is usually not treated with dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with bromocriptine has been shown to be effective without causing reexacerbation of psychotic symptoms.
Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men) will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D, Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed psychiatric examinations.
- Conditions
- Schizophrenia, Hyperprolactinemia
- Being tested
- Bromocriptin
- Keywords
- Schizophrenia, Hyperprolactinemia, Risperidone, Bromocriptin
- Medical subject headings
- Schizophrenia, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromocriptinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolactin
LH
FSH
Testosterone
Estradiol
Secondary outcomes (3)
PANSS
HAM-D
Simpson Angus Scale (SAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startMay 2006
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Maier, MD, Principal investigator, University of Bonn, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315081
- Sponsor's protocol ID
- 150-05
- Status last verified
- Nov 2005
- First submitted
- 13 Apr 2006
- Last updated
- 17 Apr 2006
- Results posted
- No
Publications
Bliesener N, Yokusoglu H, Quednow BB, Klingmuller D, Kuhn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91. doi: 10.1055/s-2004-827176. No abstract available.
PubMed 15467977
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
- ClinicalTrials.gov ID
- NCT00315081
- Acronym / sponsor ID
- 150-05
- Conditions
- Schizophrenia, Hyperprolactinemia
- Keywords
- Schizophrenia, Hyperprolactinemia, Risperidone, Bromocriptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- May 2006
- Study completion
- May 2008
- First posted
- 17 Apr 2006 (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.
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones.
Detailed description
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have been successfully medicated for years with dopamine agonists like bromocriptine.
In patients with psychiatric diseases hyperprolactinemia is usually not treated with dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with bromocriptine has been shown to be effective without causing reexacerbation of psychotic symptoms.
Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men) will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D, Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed psychiatric examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female and male schizophrenic patients.
- Antipsychotic treatment with risperidone.
- Diagnosis of a clinically relevant hyperprolactinemia.
- No indication of disturbance of the somato-, cortico or thyreotropic hypophysis-axis (IGF-1, cortisol, ACTH, TSH, FT3, FT4)
Key exclusion criteria (3 listed)
- Severe somatic disease, especially coronary disease.
- Acute psychotic exacerbation.
- Pregnancy
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 |
|---|---|---|
| Bromocriptin | Drug | – |
Primary outcome
Prolactin
LH
FSH
Testosterone
Estradiol
3 secondary outcomes
PANSS
HAM-D
Simpson Angus Scale (SAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2006.
- Background: PubMed 15467977Bliesener N, Yokusoglu H, Quednow BB, Klingmuller D, Kuhn KU. Usefulness of bromocriptine in the treatment of amisulpride-induced hyperprolactinemia: a case report. Pharmacopsychiatry. 2004 Jul;37(4):189-91. doi: 10.1055/s-2004-827176. No abstract available.
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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.
Wolfgang Maier, MD principal investigator
University of Bonn, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromocriptin in people with Schizophrenia and Hyperprolactinemia, run by University Hospital, Bonn at 1 site in Germany.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2006. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kai-Uwe Kuehn, MD (0049-(0)228-287-5681, kai-uwe.kuehn@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolactin. The study lists 5 primary outcomes in all. 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 NCT00315081, which also lists 1 linked publication.
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 17 Apr 2006.