Clozapine-induced HypersalivationPhase 3CIHNCT00534573
Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation
A Phase 3 study testing Amisulpride, Moclobemide in people with Clozapine-induced Hypersalivation, run by Beersheva Mental Health Center at 1 site in Israel.
Trial summary
Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Clozapine-induced Hypersalivation
- What is being tested?
- Amisulpride, Moclobemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Jan 2009
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years, male or female
- DSM-IV criteria for schizophrenia
- Clozapine treatment
- At least 2 scores on the Nocturnal Hypersalivation Rating Scale (NHRS)
Who cannot join
- Evidence of organic brain damage, mental retardation, alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center
Be'er Sheva, Haifa
About this study
Official title: Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind
Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance.
In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide.
The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.
Read the detailed description
The pilot study will be conducted in two mental health centers. In order to examine our hypothesis, we will use an add-on design. Into the study will be enrolled 50 patients with schizophrenia and schizoaffective disorder (males and females, 19-60 years old), according to the DSM-IV criteria, treated with clozapine and suffering from hypersalivation.
- Conditions
- Clozapine-induced Hypersalivation
- Being tested
- Amisulpride, Moclobemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride, MoclobemideDrug
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
| Study group | Role | What they receive |
|---|---|---|
| Moclobemide, | Active comparator | treatment during 2 weeks Receives: Drug: Amisulpride, Moclobemide |
| Amisulpride | Active comparator | Comparison Receives: Drug: Amisulpride, Moclobemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersalivation will be assessed by subjective and objective tools. Clinical global impression (CGI) patient's self assessment will be taken as subjective tool and NHRS as an objective assessment tool.
NHRS, CGI
Measured: every two days
Secondary outcomes (1)
CGI, NHRS
CGI, NHRS
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionJan 2009
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 Clozapine-induced HypersalivationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Tirat Carmel Mental Health Center
- Responsible party
- Principal investigator, Vladimir Lerner, Beersheva Mental Health Center
- Investigators
- Vladimir Lerner, MD, PhD, Principal investigator, Be'er Sheva Mental Health CenterAnatoly Kreinin, MD, PhD, Principal investigator, Tirat HaKarmel Mental Health CenterChanoch Miodownik, MD, Study director, Be'er Sheva Mental Health CenterIgor Libov, Study director, Be'er Sheva Mental Health CenterAlexander Grinshpoon, MD, Study director, Tirat HaKarmel Mental Health CenterDiana Shestakova, MD, Study director, Tirat HaKarmel Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534573
- Sponsor's protocol ID
- LCK4569
- Other IDs
- ISRCTN4569, ISRCTN4569
- Acronym
- CIH
- Status last verified
- Nov 2009
- First submitted
- 24 Sep 2007
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kreinin A, Miodownik C, Sokolik S, Shestakova D, Libov I, Bergman J, Lerner V. Amisulpride versus moclobemide in treatment of clozapine-induced hypersalivation. World J Biol Psychiatry. 2011 Dec;12(8):620-6. doi: 10.3109/15622975.2010.527370. Epub 2010 Oct 21.
PubMed 20964499
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind
- ClinicalTrials.gov ID
- NCT00534573
- Acronym / sponsor ID
- CIH / LCK4569
- Conditions
- Clozapine-induced Hypersalivation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Collaborators
- Tirat Carmel Mental Health Center
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Sep 2007 (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.
Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance.
In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide.
The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.
Detailed description
The pilot study will be conducted in two mental health centers. In order to examine our hypothesis, we will use an add-on design. Into the study will be enrolled 50 patients with schizophrenia and schizoaffective disorder (males and females, 19-60 years old), according to the DSM-IV criteria, treated with clozapine and suffering from hypersalivation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moclobemide, | Active comparator | Drug: Amisulpride, Moclobemidetreatment during 2 weeks |
| Amisulpride | Active comparator | Drug: Amisulpride, MoclobemideComparison |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years, male or female
- DSM-IV criteria for schizophrenia
- Clozapine treatment
- At least 2 scores on the Nocturnal Hypersalivation Rating Scale (NHRS)
Key exclusion criteria (1 listed)
- Evidence of organic brain damage, mental retardation, alcohol or drug abuse
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 |
|---|---|---|
| Amisulpride, MoclobemideAmisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout | Drug | Amisulpride, Moclobemide, |
Primary outcome
Hypersalivation will be assessed by subjective and objective tools. Clinical global impression (CGI) patient's self assessment will be taken as subjective tool and NHRS as an objective assessment tool.
Time frame: every two days
NHRS, CGI
1 secondary outcome
CGI, NHRS
Time frame: two weeks
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 26 Jul 2012.
- Derived from this study: PubMed 20964499Kreinin A, Miodownik C, Sokolik S, Shestakova D, Libov I, Bergman J, Lerner V. Amisulpride versus moclobemide in treatment of clozapine-induced hypersalivation. World J Biol Psychiatry. 2011 Dec;12(8):620-6. doi: 10.3109/15622975.2010.527370. Epub 2010 Oct 21.
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.
Vladimir Lerner, MD, PhD principal investigator
Be'er Sheva Mental Health Center
Anatoly Kreinin, MD, PhD principal investigator
Tirat HaKarmel Mental Health Center
Chanoch Miodownik, MD study director
Be'er Sheva Mental Health Center
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 Amisulpride, Moclobemide in people with Clozapine-induced Hypersalivation, run by Beersheva Mental Health Center at 1 site in Israel.
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 1 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 26 Jul 2012. 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 Israel. 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?
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?
Hypersalivation will be assessed by subjective and objective tools. Clinical global impression (CGI) patient's self assessment will be taken as subjective tool and NHRS as an objective assessment tool. (time frame: every two days). 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 NCT00534573, 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 26 Jul 2012.