Acute ManiaPhase 4NCT00931723
Adult Bipolar Mania
A Phase 4 study testing Quetiapine fumarate XR and Lithium in people with Acute Mania, run by AstraZeneca at 65 sites in 9 countries.
Trial summary
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Mania
- What is being tested?
- Quetiapine fumarate XR and Lithium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 65 sitesin 9 countries
- Study dates
- Jun 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provision of informed consent before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
- Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
Who cannot join
- The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
- The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
- The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
Trial locations and contacts
65 sites in 9 countries.
65 sites in 9 countries
India9 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karna
Research Site
Cedex, Cedex
Research Site
Jaipur, Rajasthan
Research Site
Kanpur, Uttar Prad
Research Site
Mangalore, Karna
Research Site
Manipal, Karna
Research Site
Nashik, Mahara
Research Site
Visakhapatnam, Andh Prad
Poland8 sites
Research Site
Bydgoszcz, Poland
Research Site
Cedex, Cedex
Research Site
Choroszcz, Poland
Research Site
Gorlice
Research Site
Katowice
Research Site
Krakow
Research Site
Lublin
Research Site
Poznan
Russia8 sites
Research Site
Arkhangelsk
Research Site
Cedex, Cedex
Research Site
Chita
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Saratov
Research Site
Voronezh
Ukraine8 sites
Research Site
Cedex, Cedex
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv, Ukraine
Research Site
Kiev, Ukraine
Research Site
Kiev
Research Site
Odesa
Research Site
Vinnitsia
Bulgaria7 sites
Research Site
Burgas, Bulgaria
Research Site
Cedex, Cedex
Research Site
Kazanlak
Research Site
Pazardzhik
Research Site
Plovdiv
Research Site
Radnevo, Bulgaria
Research Site
Sofia
Germany7 sites
Research Site
Berlin, State of Berlin
Research Site
Berlin
Research Site
Cedex, Cedex
Research Site
Cologne, North Rhine-Westphalia
Research Site
Mannheim
Research Site
München
Research Site
Nuremberg
South Africa7 sites
Research Site
Bloemfontein, Free State
Research Site
Cape Town
Research Site
Cedex, Cedex
Research Site
Johannesburg
Research Site
Port Elizabeth
Research Site
Vereeniging, Free State
Research Site
Worcester, W Cape
Israel6 sites
Research Site
Bat Yam
Research Site
Beer Ya'acov
Research Site
Cedex, Cedex
Research Site
Haifa
Research Site
Petah Tikva
Research Site
Tel HaShomer
Belgium5 sites
Research Site
Cedex, Cedex
Research Site
Dendermonde
Research Site
Montignies-sur-Sambre, Belgium
Research Site
Overpelt, Belgium
Research Site
Tournai
About this study
Official title: An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).
- Conditions
- Acute Mania
- Being tested
- Quetiapine fumarate XR, Lithium, Placebo
- Keywords
- Acute Mania, Mania, Adults, Seroquel, Acute Mania in Adult Patients
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarate XRDrug
Also called Seroquel XR
Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
LithiumDrug
Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
PlaceboDrug
Oral treatment twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Seroquel XR and Lithium Receives: Drug: Quetiapine fumarate XR; Drug: Lithium |
| 2 | Placebo comparator | Seroquel XR and placebo Receives: Drug: Quetiapine fumarate XR; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Measured: Change in YMRS total score from baseline to Day 43.
Secondary outcomes (20)
The Number of Patients With Clinically Significant Response.
The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.
Measured: 43 days (from baseline to Day 43)
Remission
The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.
The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Measured: Days 8 to 43
Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)
The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.
Measured: Change from baseline to Day 43.
Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)
The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.
Measured: Change from baseline to Day 43
Improvement of Overall Bipolar Illness
The number of patients with a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment at Day 43 was calculated.
The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.
Measured: Day 43.
Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms.
Measured: Change from baseline to Day 43.
Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in PANSS Activation Subscale Score
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in PANSS Positive Subscale Score
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 1
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 2
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 3
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 4
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 5
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 6
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 7
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 8
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 9
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 10
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 11
The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Measured: Change from baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ManiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Castiglione, Study director, AstraZenecaMichel Bourin, Professeur, Principal investigator, Neurobiologie de l'anxiété et de la dépression Faculté de Médecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931723
- Sponsor's protocol ID
- D144AC00003
- Status last verified
- Mar 2012
- First submitted
- 29 Jun 2009
- Last updated
- 19 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bourin MS, Severus E, Schronen JP, Gass P, Szamosi J, Eriksson H, Chandrashekar H. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study. Int J Bipolar Disord. 2014 Nov 8;2:14. doi: 10.1186/s40345-014-0014-9. eCollection 2014.
PubMed 25505693
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania
- ClinicalTrials.gov ID
- NCT00931723
- Acronym / sponsor ID
- D144AC00003
- Conditions
- Acute Mania
- Keywords
- Acute Mania, Mania, Adults, Seroquel, Acute Mania in Adult Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 19 Apr 2012
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 if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Quetiapine fumarate XR, Drug: LithiumSeroquel XR and Lithium |
| 2 | Placebo comparator | Drug: Quetiapine fumarate XR, Drug: PlaceboSeroquel XR and placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
- Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
Key exclusion criteria (3 listed)
- The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
- The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
- The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
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 |
|---|---|---|
| Quetiapine fumarate XRAlso: Seroquel XROral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. | Drug | 1, 2 |
| LithiumOral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator. | Drug | 1 |
| PlaceboOral treatment twice daily. | Drug | 2 |
Primary outcome
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
Time frame: Change in YMRS total score from baseline to Day 43.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
20 secondary outcomes
The Number of Patients With Clinically Significant Response.
Time frame: 43 days (from baseline to Day 43)
Remission
Time frame: Days 8 to 43
Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)
Time frame: Change from baseline to Day 43.
Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)
Time frame: Change from baseline to Day 43
Improvement of Overall Bipolar Illness
Time frame: Day 43.
Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Change from baseline to Day 43.
Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in PANSS Activation Subscale Score
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in PANSS Positive Subscale Score
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 1
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 2
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 3
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 4
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 5
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 6
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 7
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 8
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 9
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 10
Time frame: Change from baseline to Day 43
Change From Baseline to Day 43 in Each YMRS Item Score No. 11
Time frame: Change from baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25505693Bourin MS, Severus E, Schronen JP, Gass P, Szamosi J, Eriksson H, Chandrashekar H. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study. Int J Bipolar Disord. 2014 Nov 8;2:14. doi: 10.1186/s40345-014-0014-9. eCollection 2014.
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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.
Michael Castiglione study director
AstraZeneca
Michel Bourin, Professeur principal investigator
Neurobiologie de l'anxiété et de la dépression Faculté de Médecine
65 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine fumarate XR and Lithium in people with Acute Mania, run by AstraZeneca at 65 sites in 9 countries.
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 3 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in India, Poland, Russia, Ukraine, Bulgaria and 4 more countries. 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.
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?
Yes. Results are posted in the registry (first posted 19 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) (time frame: Change in YMRS total score from baseline to Day 43.). 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 NCT00931723, 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 Apr 2012.