A Phase 4 interventional study of quetiapine XR and placebo in Panic Disorder, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-21.
Sponsored by Indiana University · Phase 4, Interventional, and Treatment
The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.
This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group (2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance was determined either historically or prospectively. Patients were randomized if they remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually titrated from 50 to 400 mg/day.
Conclusions: This proof-of-concept RCT did not support the efficacy of this treatment strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important limitations were the small sample size, and the relatively low average dose of quetiapine XR used.
250 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.
This study's enrollment of 26 is below the median of 80 across 195 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy \& the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, \& 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
Drug: quetiapine XR
Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
Drug: placebo
Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
Also known as: Seroquel SR, Seroquel XR
Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
Also known as: Astra Zeneca placebo
Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores
Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.
Time frame: Baseline and the end of 8 weeks of treatment
Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).
Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.
Time frame: Comparing baseline and the end of 8 weeks of treatment
| Milestone | Quetiapine SR | Placebo |
|---|---|---|
| Started | 13 | 13 |
| Completed | 10 | 11 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Intercurrent illness | 0 | 1 |
Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.
| units on a scale | Quetiapine SR | Placebo |
|---|---|---|
| Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores | -5.3 ± 4.7 | -5.6 ± 4.8 |
Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.
| units on a scale | Quetiapine XR | Placebo |
|---|---|---|
| Decrease in HAM-D scores | 5.0 ± 5.2 | 3.8 ± 3.6 |
| Decrease in HAM-A scores | 6.8 ± 8.1 | 5.5 ± 4.7 |
| Increase in PSQI sleep quality scores | 1.3 ± 0.5 | 1.3 ± 1.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quietapine Group | — | 0/13 (0%) | 10/13 (76.9%) |
| Placebo Group | — | 0/13 (0%) | 5/13 (38.5%) |
| Event | Quietapine Group | Placebo Group |
|---|---|---|
| SomnolenceNervous system disorders | 10/13 | 5/13 |
| AnxietyPsychiatric disorders | 4/13 | 0/13 |
| RestlessnessNervous system disorders | 2/13 | 4/13 |
| ConstipationGastrointestinal disorders | 3/13 | 1/13 |
| Dry MouthNervous system disorders | 3/13 | 0/13 |
| DizzinessNervous system disorders | 2/13 | 3/13 |
| InsomniaNervous system disorders | 1/13 | 3/13 |
| DerealizationPsychiatric disorders | 2/13 | 0/13 |
| Increased AppetiteNervous system disorders | 1/13 | 2/13 |
| Muscle AchesMusculoskeletal and connective tissue disorders | 0/13 | 2/13 |
| Age, Categorical(Participants) | Quetiapine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 13 | 26 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Mean | 35.5 ± 9.6 | 35.5 ± 16.8 | 35.5 ± 13.2 |
| Sex: Female, Male(Participants) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 3 | 5 | 8 |
| Region of Enrollment(participants) | Quetiapine | Placebo | Total |
|---|---|---|---|
| United States | 13 | 13 | 26 |
| Panic Disorder Severity Scale(units on a scale) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Mean | 14.8 ± 3.6 | 13.7 ± 3 | 14.3 ± 3.3 |
| Clinical Global Impression-Severity Scale (CGI-S)(units on a scale) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Mean | 4.8 ± 0.8 | 4.4 ± 0.7 | 4.6 ± 0.8 |
| Hamilton Anxiety Rating Scale (HAM-A)(units on a scale) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Mean | 21.2 ± 6.8 | 17 ± 5.2 | 19.1 ± 6.0 |
| Hamilton Depression Rating Scale (HAM-D)(units on a scale) | Quetiapine | Placebo | Total |
|---|---|---|---|
| Mean | 14.6 ± 6.2 | 11.5 ± 5.1 | 13.1 ± 5.7 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indiana University