Bipolar I DisorderPhase 4ARIQUELINCT01710163
Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
A Phase 4 study testing Lithium and Aripiprazole in people with Bipolar I Disorder, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Lithium and Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2012to Jun 2015
- 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 40 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
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Institute of Psychiatry, University of São Paulo
São Paulo, São Paulo, 05403-010
Giovani Missio, +55 11 26616648, gmissio@mac.com
Ricardo Alberto Moreno, MD, PhD, +55 11 26616648, rmoreno@sti.com.br
- Recruiting
Institute of Psychiatry
São Paulo, São Paulo, 05403010
Missio
About this study
Official title: ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.
- Conditions
- Bipolar I Disorder
- Being tested
- Lithium, Aripiprazole
- Keywords
- Lithium Carbonate, Lithium, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Physiological Effects of Drugs, Antimanic Agents, Tranquilizing Agents, Central Nervous System Depressants, Psychotropic Drugs, Sensory System Agents, Antipsychotic Agents, Antidepressive Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.
AripiprazoleDrug
Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L) Receives: Drug: Lithium |
| Aripiprazole | Experimental | Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg) Receives: Drug: Aripiprazole |
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: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2015 (estimated)
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 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
- 50 participants (estimated)
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
- Investigators
- Ricardo Alberto Moreno, MD, PhD, Principal investigator, Institute of Psychiatry, University of São PauloGiovani Missio, MD, Study chair, Institute of Psychiatry, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710163
- Sponsor's protocol ID
- ARIQUELI
- Acronym
- ARIQUELI
- Status last verified
- Oct 2012
- First submitted
- 28 Jul 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Missio G, Moreno DH, Fernandes F, Bio DS, Soeiro-de-Souza MG, Rodrigues dos Santos D Jr, David DP, Costa LF, Demetrio FN, Moreno RA. The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole. Trials. 2013 Jun 27;14:190. doi: 10.1186/1745-6215-14-190.
PubMed 23805994
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
- ClinicalTrials.gov ID
- NCT01710163
- Acronym / sponsor ID
- ARIQUELI / ARIQUELI
- Conditions
- Bipolar I Disorder
- Keywords
- Lithium Carbonate, Lithium, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Oct 2012 (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 whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: LithiumPotentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L) |
| Aripiprazole | Experimental | Drug: AripiprazolePotentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg) |
Who may qualify
- Ages
- 18 to 40 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 |
|---|---|---|
| LithiumStarting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability. | Drug | Lithium |
| AripiprazoleStarting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability. | Drug | Aripiprazole |
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: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Derived from this study: PubMed 23805994Missio G, Moreno DH, Fernandes F, Bio DS, Soeiro-de-Souza MG, Rodrigues dos Santos D Jr, David DP, Costa LF, Demetrio FN, Moreno RA. The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole. Trials. 2013 Jun 27;14:190. doi: 10.1186/1745-6215-14-190.
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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.
Ricardo Alberto Moreno, MD, PhD principal investigator
Institute of Psychiatry, University of São Paulo
Giovani Missio, MD study chair
Institute of Psychiatry, University of São Paulo
2 sites 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 and Aripiprazole in people with Bipolar I Disorder, run by University of Sao Paulo at 2 sites 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: status not confirmed, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovani Missio (+ 55 11 2661 6648, gmissio@mac.com), or a site near the patient. 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: 2 years). 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 NCT01710163, 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 19 Oct 2012.