Bipolar DisorderPhase 4NCT01195363

Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

A Phase 4 study testing quetiapine SR in people with Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder
What is being tested?: quetiapine SR
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Apr 2007to Jun 2011
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

Male or female;
Age 18 years and older
Patients on:
Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR

Show all 11Show fewer

Any combination 3a, 3b, or 3c
Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14

Who cannot join

Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
Women with a positive pregnancy test or who are lactating
Women of child-bearing potential who are not practicing a clinically accepted method of contraception
Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
Patients whose clinical status requires inpatient or day hospital treatment
History of severe side effects associated with therapeutic doses of Li, DIV, LAM

Show all 9Show fewer

Alcohol or drug dependent at time of enrollment
Suicidal at time of enrollment.
Current or previous exposure to QTP

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder

Conditions: Bipolar Disorder
Being tested: quetiapine SR, quetiapine sr placebo
Keywords: bipolar disorder, mania, depression
Medical subject headings: Bipolar Disorder, Mania, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

quetiapine SRDrug
Also called Seroquel SR
quetiapine SR, dose range 200-600mg, each night QHS for 6mos
quetiapine sr placeboDrug
quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Study groups in NCT01195363
Study group	Role	What they receive
quetiapine SR	Active comparator	quetiapine SR, 200-600mg, po, qd Receives: Drug: quetiapine SR
quetiapine sr Placebo	Placebo comparator	quetiapine SR placebo, 200-600mg, po qd Receives: Drug: quetiapine sr placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
Measured: Baseline visit to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jun 2011

First posted6 Sep 2010 (estimated)
Study startApr 2007
Primary completionDec 2010
Study completionJun 2011

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.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center at San AntonioThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195363
Sponsor's protocol ID: HSC20070253H
Status last verified: Mar 2017
First submitted: 2 Sep 2010
Last updated: 23 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
ClinicalTrials.gov ID: NCT01195363
Acronym / sponsor ID: HSC20070253H
Conditions: Bipolar Disorder
Keywords: bipolar disorder, mania, depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: AstraZeneca
Study start: Apr 2007
Primary completion: Dec 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 6 Sep 2010 (estimated)
Results: Posted 12 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
quetiapine SR	Active comparator	Drug: quetiapine SRquetiapine SR, 200-600mg, po, qd
quetiapine sr Placebo	Placebo comparator	Drug: quetiapine sr placeboquetiapine SR placebo, 200-600mg, po qd

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female;
Age 18 years and older
Patients on:
Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14

Key exclusion criteria (9 listed)

Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
Women with a positive pregnancy test or who are lactating
Women of child-bearing potential who are not practicing a clinically accepted method of contraception
Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
Patients whose clinical status requires inpatient or day hospital treatment

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 SRAlso: Seroquel SRquetiapine SR, dose range 200-600mg, each night QHS for 6mos	Drug	quetiapine SR
quetiapine sr placeboquetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos	Drug	quetiapine sr Placebo

Primary outcome

Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
Time frame: Baseline visit to week 24
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.

Results and safety

Results posted to the registry on 12 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quetiapine SR, 200-600mg , po, QD	15	4
Quetiapine sr Placebo 200-600mg, po, qd	13	4

Primary outcome: Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.

Time frame: Baseline visit to week 24. Number. Unit: participants

Measure	Active Quetiapine S.R., 200-600mg, po, qd n = 15	Placebo Quetiapine S.R. 200-600mg, po, qd n = 13
MADRS	4	4
YMRS	4	4

Population analysed: Per Protocol

Adverse events

Time frame: 10/30/2007 - 6/1/2011, 2 yrs 8 mos.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mood Stabilizer Plus Quetiapine SR	0 of 15 (0%)	10 of 15 (66.7%)	Not reported
Mood Stabilizer Plus Quetiapine sr Placebo	0 of 13 (0%)	7 of 13 (53.8%)	Not reported

Limitations and caveats (from the sponsor): Overall limitations were screen failures and lost to follow-ups which led to not reaching recruitment goals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Charles Bowden, MD principal investigator

University of Texas

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 quetiapine SR in people with Bipolar Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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 11 inclusion and 9 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 23 Mar 2017. 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 United States. 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 12 Feb 2015). 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?

Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores. (time frame: Baseline visit to week 24). 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 NCT01195363.

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 23 Mar 2017.