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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR PAROXETINE HYDROCHLORIDE

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Clinical Trials for Paroxetine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00000368 Treatment of Panic Disorder: Long Term Strategies Completed National Institute of Mental Health (NIMH) Phase 3 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00000368 Treatment of Panic Disorder: Long Term Strategies Completed New York State Psychiatric Institute Phase 3 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00012558 Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Completed National Institute of Mental Health (NIMH) N/A A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.
NCT00018733 Biological Aspects of Depression and Antidepressant Drugs Completed VA Office of Research and Development N/A This study will be measuring changes in depressive symptoms over a 7 week time period. Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or Desipramine.
NCT00018759 Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients Completed SmithKline Beecham Phase 4 This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.
NCT00018759 Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients Completed VA Office of Research and Development Phase 4 This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.
NCT00025740 Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder Completed National Institute of Mental Health (NIMH) Phase 4 Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms. The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD. Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Paroxetine Hydrochloride

Condition Name

Condition Name for Paroxetine Hydrochloride
Intervention Trials
Depression 25
Major Depressive Disorder 23
Depressive Disorder 19
Panic Disorder 16
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Condition MeSH

Condition MeSH for Paroxetine Hydrochloride
Intervention Trials
Depression 89
Depressive Disorder 77
Disease 75
Depressive Disorder, Major 51
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Clinical Trial Locations for Paroxetine Hydrochloride

Trials by Country

Trials by Country for Paroxetine Hydrochloride
Location Trials
United States 481
Canada 40
Germany 30
China 27
Japan 17
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Trials by US State

Trials by US State for Paroxetine Hydrochloride
Location Trials
New York 33
California 28
Pennsylvania 27
Florida 23
Texas 22
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Clinical Trial Progress for Paroxetine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Paroxetine Hydrochloride
Clinical Trial Phase Trials
Phase 4 70
Phase 3 51
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Paroxetine Hydrochloride
Clinical Trial Phase Trials
Completed 167
Terminated 17
Recruiting 15
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Clinical Trial Sponsors for Paroxetine Hydrochloride

Sponsor Name

Sponsor Name for Paroxetine Hydrochloride
Sponsor Trials
GlaxoSmithKline 52
National Institute of Mental Health (NIMH) 16
Sanofi 12
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Sponsor Type

Sponsor Type for Paroxetine Hydrochloride
Sponsor Trials
Other 173
Industry 129
NIH 24
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