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| ID | Type | Description | Link |
|---|---|---|---|
| IRUSQUET0445 | Other Grant/Funding Number | Astra Zeneca |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine XR | Active Comparator | 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). |
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| Placebo | Placebo Comparator | Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine XR | Drug | Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and the end of 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W. Goddard, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Outpatient Center, Psychiatry | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26379759 | Derived | Goddard AW, Mahmud W, Medlock C, Shin YW, Shekhar A. A controlled trial of quetiapine XR coadministration treatment of SSRI-resistant panic disorder. Ann Gen Psychiatry. 2015 Sep 15;14:26. doi: 10.1186/s12991-015-0064-0. eCollection 2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine SR | quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg. |
| FG001 | Placebo | placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg. |
| BG001 | Placebo | Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and the end of 8 weeks of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quietapine Group | quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Goddard, M.D. | UCSF Fresno | 559-499-6580 | agoddard@fresno.ucsf.edu |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| placebo | Drug | Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication. |
|
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| Comparing baseline and the end of 8 weeks of treatment |
| Intercurrent illness |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Panic Disorder Severity Scale | Possible range 0-28 (7 questions, each scored from 0 to 4, with higher numbers indicating more severe panic symptoms). Mean (Standard Deviation) | Mean | Standard Deviation | units on a scale |
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| Clinical Global Impression-Severity Scale (CGI-S) | CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, where 1 =normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Anxiety Rating Scale (HAM-A) | Hamilton Anxiety Rating Scale (HAM-A) is a questionnaire used by clinicians to rate the severity of a patient's anxiety. The scale consists of 14 items designed to assess the severity of a patient's anxiety, each of which is rated on a scale of 0 to 4, with 4 being the most severe. Total scores can range from 0 to 56. | Mean | Standard Deviation | units on a scale |
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| Hamilton Depression Rating Scale (HAM-D) | The HAM-D is a questionnaire with 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale. The total scores indicate levels of depression, where 0-7= normal; 8-13 = mild depression; 14-18 = moderate depression; 19-22 = severe depression; and 23 or greater = very severe depression. | Mean | Standard Deviation | units on a scale |
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| Pittsburgh Sleep Quality Index (PSQI) sleep hours | The PSQI sleep hours subscale is a self-reported measure of the number of hours patients slept per night over the past month. | Mean | Standard Deviation | hours slept per night |
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| Pittsburgh Sleep Quality Index (PSQI) sleep quality | The PSQI sleep quality subscale is a self-reported measure of the patient's sleep quality over the past month, with a possible range of 0-3, where 0 = very good; 1 = fairly good; 2= fairly bad; and 3 = very bad. | Mean | Standard Deviation | units on a scale |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Comparing baseline and the end of 8 weeks of treatment |
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| 0 |
| 13 |
| 10 |
| 13 |
| EG001 | Placebo Group | placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication. | 0 | 13 | 5 | 13 |
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry Mouth | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Restlessness | Nervous system disorders | Non-systematic Assessment |
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| Derealization | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Increased Appetite | Nervous system disorders | Non-systematic Assessment |
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| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Weight Loss | Gastrointestinal disorders | Non-systematic Assessment |
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| Shakiness | Nervous system disorders | Non-systematic Assessment |
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| Muscle Aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Weight Gain | Gastrointestinal disorders | Non-systematic Assessment |
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Increase in PSQI sleep quality scores |
|