A Phase 4 interventional study of quetiapine SR and quetiapine sr placebo in Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 28 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients on:
Exclusion Criteria:
quetiapine SR, 200-600mg, po, qd
Drug: quetiapine SR
quetiapine SR placebo, 200-600mg, po qd
Drug: quetiapine sr placebo
quetiapine SR, dose range 200-600mg, each night QHS for 6mos
Also known as: Seroquel SR
quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
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.
Time frame: Baseline visit to week 24
Participants were recruited in our University, Center for Healthcare Services, and by televison ads between Oct 2007 and January 2011.
| Milestone | Quetiapine SR, 200-600mg , po, QD | Quetiapine sr Placebo 200-600mg, po, qd |
|---|---|---|
| Started | 15 | 13 |
| Completed | 4 | 4 |
| Not completed | 11 | 9 |
| Withdrew: Lost to follow-up | 7 | 4 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Lack of efficacy | 0 | 4 |
| Withdrew: Incarceration | 1 | 0 |
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.
| participants | Active Quetiapine S.R., 200-600mg, po, qd | Placebo Quetiapine S.R. 200-600mg, po, qd |
|---|---|---|
| MADRS | 4 | 4 |
| YMRS | 4 | 4 |
Collected over 10/30/2007 - 6/1/2011, 2 yrs 8 mos.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mood Stabilizer Plus Quetiapine SR | — | 0/15 (0%) | 10/15 (66.7%) |
| Mood Stabilizer Plus Quetiapine sr Placebo | — | 0/13 (0%) | 7/13 (53.8%) |
| Event | Mood Stabilizer Plus Quetiapine SR | Mood Stabilizer Plus Quetiapine sr Placebo |
|---|---|---|
| drowsiness/sedationInvestigations | 7/15 | 3/13 |
| dry mouthGeneral disorders | 4/15 | 2/13 |
| headacheGeneral disorders | 1/15 | 2/13 |
| increased appetiteMetabolism and nutrition disorders | 1/15 | 2/13 |
| joint painGeneral disorders | 2/15 | 0/13 |
| interrupted sleepInvestigations | 2/15 | 0/13 |
| muscle weaknessMusculoskeletal and connective tissue disorders | 2/15 | 0/13 |
| nauseaGastrointestinal disorders | 2/15 | 0/13 |
| Age, Categorical(Participants) | Active Quetiapine SR | Quetiapine SR Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 13 | 28 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active Quetiapine SR | Quetiapine SR Placebo | Total |
|---|---|---|---|
| Mean | 35.5 ± 10.1 | 32.1 ± 9.8 | 34 ± 9.9 |
| Sex: Female, Male(Participants) | Active Quetiapine SR | Quetiapine SR Placebo | Total |
|---|---|---|---|
| Female | 8 | 11 | 19 |
| Male | 7 | 2 | 9 |
| Region of Enrollment(participants) | Active Quetiapine SR | Quetiapine SR Placebo | Total |
|---|---|---|---|
| United States | 15 | 13 | 28 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio