Bipolar I DisorderPhase 4LICAVALNCT00976794
Efficacy of Combined Treatment for Young Bipolar I Disorder
A Phase 4 study testing lithium plus carbamazepine and lithium plus valproate in people with Bipolar I Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- lithium plus carbamazepine and lithium plus valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jun 2012
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
- The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.
Who cannot join
- Schizophrenia or schizoaffective disorder
- Mental retardation
- Unstable clinical diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry - University of São Paulo
São Paulo, São Paulo
About this study
Official title: Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients
The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.
Read the detailed description
After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:
Group I: lithium + valproic acid
Group II: lithium + carbamazepine
Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.
During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.
- Conditions
- Bipolar I Disorder
- Being tested
- lithium plus carbamazepine, lithium plus valproate
- Keywords
- BD I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithium plus carbamazepineDrug
Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability
lithium plus valproateDrug
Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.
Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| lithium plus carbamazepine | Experimental | combination of the two drugs in standard dosage Receives: Drug: lithium plus carbamazepine |
| lithium plus valproate | Active comparator | combination of the two drugs in standard dosage Receives: Drug: lithium plus valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.
Measured: August 2012
Secondary outcomes (1)
Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study
Measured: August 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976794
- Sponsor's protocol ID
- 2898
- Acronym
- LICAVAL
- Status last verified
- Jul 2013
- First submitted
- 11 Sep 2009
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004.
PubMed 15820265Missio G, Moreno DH, Demetrio FN, Soeiro-de-Souza MG, Dos Santos Fernandes F, Barros VB, Moreno RA. A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study. Trials. 2019 Oct 26;20(1):608. doi: 10.1186/s13063-019-3655-2.
PubMed 31655626Campos RN, Costa LF, Bio DS, Soeiro de Souza MG, Garcia CR, Demetrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72. doi: 10.1186/1745-6215-11-72.
PubMed 20573223
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients
- ClinicalTrials.gov ID
- NCT00976794
- Acronym / sponsor ID
- LICAVAL / 2898
- Conditions
- Bipolar I Disorder
- Keywords
- BD I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Sep 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 efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.
Detailed description
After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:
Group I: lithium + valproic acid
Group II: lithium + carbamazepine
Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.
During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium plus carbamazepine | Experimental | Drug: lithium plus carbamazepinecombination of the two drugs in standard dosage |
| lithium plus valproate | Active comparator | Drug: lithium plus valproatecombination of the two drugs in standard dosage |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
- The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.
Key exclusion criteria (3 listed)
- Schizophrenia or schizoaffective disorder
- Mental retardation
- Unstable clinical diseases
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 |
|---|---|---|
| lithium plus carbamazepineLithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability | Drug | lithium plus carbamazepine |
| lithium plus valproateLithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability. | Drug | lithium plus valproate |
Primary outcome
The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.
Time frame: August 2012
1 secondary outcome
Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study
Time frame: August 2012
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 12 Jul 2013.
- Background: PubMed 15820265Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004.
- Derived from this study: PubMed 31655626Missio G, Moreno DH, Demetrio FN, Soeiro-de-Souza MG, Dos Santos Fernandes F, Barros VB, Moreno RA. A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study. Trials. 2019 Oct 26;20(1):608. doi: 10.1186/s13063-019-3655-2.
- Derived from this study: PubMed 20573223Campos RN, Costa LF, Bio DS, Soeiro de Souza MG, Garcia CR, Demetrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72. doi: 10.1186/1745-6215-11-72.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 lithium plus carbamazepine and lithium plus valproate in people with Bipolar I Disorder, run by University of Sao Paulo at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 12 Jul 2013. 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 Brazil. 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 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?
The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study. (time frame: August 2012). 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 NCT00976794, which also lists 3 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 12 Jul 2013.