SchizophreniaPhase 4CMCOBakuNCT00947375
Lamictal TM, Haloperidol Decanoate in Schizophrenia
A Phase 4 study testing Lamictal TM and Haloperidol Decanoate in people with Schizophrenia, run by Central Mental Clinic for Outpatients of Baku City at 1 site in Azerbaijan.
Trial summary
The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lamictal TM and Haloperidol Decanoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteAzerbaijan
- Study dates
- Jan 2005to Jan 2007
- Phase
- Phase 4
- 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 from 18-60;
- both gender;
- resistant scizophrenia patients;
- previous treatment history;
- verbal resistant hallucinosis.
Who cannot join
- Display an acute systemic medical disorder or a medical disorder requiring frequent changes in medication;
- Display a history of seizures, cerebrovascular disease, structural brain damage, from trauma, focal neurological sings on examination, or evidence of any progressive neurological disorder, substance dependence (except tobacco).
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site
Central Mental Clinic for Outpatients of Baku City
Baku, AZ0010
About this study
Official title: The Effect of Lamictal TM Augmentation of Haloperidol Decanoate in the Treatment of Resistant Schizophrenia Predominantly by Verbal Resistant Hallucinosis: Randomized, Double-blind, Placebo-controlled, Study
The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.
Nadir A.Aliyev \& Zafar N.Aliyev
Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic
Abstract:
OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.
Read the detailed description
METHOD:A structured clinical interview, for DSM-IV Axis I Disorder, Patient Edition, was used to diagnose schizophrenia according to DSM-IV. Three hundred fifty patients were studied. The patients were then randomly divided into two groups on 175 subjects in each group. First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. Data for clinical assessments were collected at weeks 0, 6 and 12 weeks. The expressiveness of psychopathology was estimated on PANSS. Test response in both groups was defined as a reduction in the PANSS by using analysis of variance and chi-square tests.
- Conditions
- Schizophrenia
- Being tested
- Lamictal TM, Haloperidol Decanoate
- Keywords
- schizophrenia, lamictal TM, haloperidol decanoate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamictal TMDrug
First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and Lamictal TM 150-200 mg in day per so for 12 weeks.
Haloperidol DecanoateDrug
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Starch | Experimental | In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial. Receives: Drug: Lamictal TM; Drug: Haloperidol Decanoate |
| Lifestyle councelling | No intervention | May be required to comply with US Public Law 110-85, Section 801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
Measured: 2006
Secondary outcomes (1)
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
Measured: 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2006
- Study completionJan 2007
Why it stopped: All of the mentioned aim and objectives were achieved before the February 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Mental Clinic for Outpatients of Baku City
- Sponsor type
- University, hospital or other
- Investigators
- Nadir A Aliyev, PHD, MD, Principal investigator, Outpatient service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947375
- Sponsor's protocol ID
- Nadir
- Acronym
- CMCOBaku
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lamictal TM Augmentation of Haloperidol Decanoate in the Treatment of Resistant Schizophrenia Predominantly by Verbal Resistant Hallucinosis: Randomized, Double-blind, Placebo-controlled, Study
- ClinicalTrials.gov ID
- NCT00947375
- Acronym / sponsor ID
- CMCOBaku / Nadir
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, lamictal TM, haloperidol decanoate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All of the mentioned aim and objectives were achieved before the February 2007
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Central Mental Clinic for Outpatients of Baku CityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 28 Jul 2009 (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 this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.
Nadir A.Aliyev \& Zafar N.Aliyev
Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic
Abstract:
OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.
Detailed description
METHOD:A structured clinical interview, for DSM-IV Axis I Disorder, Patient Edition, was used to diagnose schizophrenia according to DSM-IV. Three hundred fifty patients were studied. The patients were then randomly divided into two groups on 175 subjects in each group. First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. Data for clinical assessments were collected at weeks 0, 6 and 12 weeks. The expressiveness of psychopathology was estimated on PANSS. Test response in both groups was defined as a reduction in the PANSS by using analysis of variance and chi-square tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starch | Experimental | Drug: Lamictal TM, Drug: Haloperidol DecanoateIn these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial. |
| Lifestyle councelling | No intervention | –May be required to comply with US Public Law 110-85, Section 801 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age from 18-60;
- both gender;
- resistant scizophrenia patients;
- previous treatment history;
- verbal resistant hallucinosis.
Key exclusion criteria (2 listed)
- Display an acute systemic medical disorder or a medical disorder requiring frequent changes in medication;
- Display a history of seizures, cerebrovascular disease, structural brain damage, from trauma, focal neurological sings on examination, or evidence of any progressive neurological disorder, substance dependence (except tobacco).
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 |
|---|---|---|
| Lamictal TMFirst group patients received either haloperidol deaconate 50 mg in weekly intramuscular and Lamictal TM 150-200 mg in day per so for 12 weeks. | Drug | Starch |
| Haloperidol DecanoateSecond group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. | Drug | Starch |
Primary outcome
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
Time frame: 2006
1 secondary outcome
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
Time frame: 2007
Results and safety
The study was stopped early (reason given: All of the mentioned aim and objectives were achieved before the February 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2009.
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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.
Nadir A Aliyev, PHD, MD principal investigator
Outpatient service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamictal TM and Haloperidol Decanoate in people with Schizophrenia, run by Central Mental Clinic for Outpatients of Baku City at 1 site in Azerbaijan.
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: stopped early, as of the sponsor's last update on 28 Jul 2009. 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 Azerbaijan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: All of the mentioned aim and objectives were achieved before the February 2007). 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?
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. (time frame: 2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2009.