SchizophreniaNCT00345982
Augmenting Clozapine With Sertindole - SERCLOZ
A study testing Serdolect in people with Schizophrenia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Serdolect
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Sep 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD10 diagnosis of schizophrenia (F20.0-3)
- Clozapine treatment minimum 6 months
- Total PANSS >65
- No antipsychotic other than clozapine drug 1 month prior inclusion
Who cannot join
- QTc >500 ms
- Violence to SPC of clozapine or Serdolect
- Major depression
- Significant substance misuse interfering with participating in the study
- Cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.
Read the detailed description
Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.
- Conditions
- Schizophrenia
- Being tested
- Serdolect, placebo
- Keywords
- Schizophrenia, Treatment-resistant, sertindole, clozapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerdolectDrug
Also called sertindole
16 mg, 12 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sertindole 16 mg Receives: Drug: Serdolect |
| B | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS total score
Measured: 12 weeks
Secondary outcomes (8)
GAF
Measured: 12 weeks
WHOQOL-BREF
Measured: 12 weeks
CGI
Measured: 12 weeks
DAI
Measured: 12 weeks
Cognitive test
Measured: 12 weeks
Fasting glucose
Measured: 12 weeks
Lipids
Measured: 12 weeks
Hb1Ac
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Jimmi Nielsen, M.D., Principal investigator, Aalborg Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345982
- Sponsor's protocol ID
- 2005/150
- Status last verified
- Sep 2010
- First submitted
- 28 Jun 2006
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen J, Emborg C, Gydesen S, Dybbro J, Aagaard J, Haderup K, Glyngdal P, Fabricius S, Thode D, Lublin H, Andersen T, Damkier P, Taylor D. Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol. 2012 Apr;32(2):173-8. doi: 10.1097/JCP.0b013e318248dfb8.
PubMed 22367659Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Acta Psychiatr Scand. 2012 Jul;126(1):31-9. doi: 10.1111/j.1600-0447.2012.01840.x. Epub 2012 Feb 22.
PubMed 22356584
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
- ClinicalTrials.gov ID
- NCT00345982
- Acronym / sponsor ID
- 2005/150
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Treatment-resistant, sertindole, clozapine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Sep 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Jun 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.
The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.
Detailed description
Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SerdolectSertindole 16 mg |
| B | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICD10 diagnosis of schizophrenia (F20.0-3)
- Clozapine treatment minimum 6 months
- Total PANSS >65
- No antipsychotic other than clozapine drug 1 month prior inclusion
Key exclusion criteria (5 listed)
- QTc >500 ms
- Violence to SPC of clozapine or Serdolect
- Major depression
- Significant substance misuse interfering with participating in the study
- Cardiovascular disease
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 |
|---|---|---|
| SerdolectAlso: sertindole16 mg, 12 weeks | Drug | A |
| placeboplacebo | Drug | B |
Primary outcome
PANSS total score
Time frame: 12 weeks
8 secondary outcomes
GAF
Time frame: 12 weeks
WHOQOL-BREF
Time frame: 12 weeks
CGI
Time frame: 12 weeks
DAI
Time frame: 12 weeks
Cognitive test
Time frame: 12 weeks
Fasting glucose
Time frame: 12 weeks
Lipids
Time frame: 12 weeks
Hb1Ac
Time frame: 12 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 27 Sep 2010.
- Derived from this study: PubMed 22367659Nielsen J, Emborg C, Gydesen S, Dybbro J, Aagaard J, Haderup K, Glyngdal P, Fabricius S, Thode D, Lublin H, Andersen T, Damkier P, Taylor D. Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol. 2012 Apr;32(2):173-8. doi: 10.1097/JCP.0b013e318248dfb8.
- Derived from this study: PubMed 22356584Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Acta Psychiatr Scand. 2012 Jul;126(1):31-9. doi: 10.1111/j.1600-0447.2012.01840.x. Epub 2012 Feb 22.
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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.
Jimmi Nielsen, M.D. principal investigator
Aalborg Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serdolect in people with Schizophrenia, run by University of Aarhus 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 4 inclusion and 5 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 27 Sep 2010. 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. Some participants in this study may receive a placebo. 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?
PANSS total score (time frame: 12 weeks). 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 NCT00345982, which also lists 2 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 27 Sep 2010.