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Generated: February 20, 2019

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CLINICAL TRIALS PROFILE FOR NORTRIPTYLINE HYDROCHLORIDE

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Clinical Trials for Nortriptyline Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00000375 Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder Completed National Institute of Mental Health (NIMH) Phase 4 The purpose of this study is to compare the safety and effectiveness of two treatments to prevent relapses in seriously ill patients with major depressive disorder (MDD) who have responded to electroconvulsive therapy (ECT). Patients will either continue to receive ECT (continuation electroconvulsive therapy [C-ECT]), or they will be treated with antidepressant medications. ECT is a highly effective treatment for MDD; however, relapses are a major concern. To prevent relapse in patients who have responded to ECT, the common treatment is antidepressants as continuation therapy (following the initial therapy in order to continue treating the disorder). Relapses, however, can still occur even after antidepressant continuation therapy. This study will evaluate a potent antidepressant combination in order to prevent relapse. C-ECT is another option that needs to be tested. If the patient responds to the first round of ECT, he/she will be assigned randomly (like tossing a coin) to either continue receiving ECT or to receive an antidepressant combination of nortriptyline plus lithium (NOR-Li) for 6 months. The patient will have psychological tests before, shortly after, and 3 months after the first round of ECT, and at the end of the 6-month continuation trial. Patients will be monitored for symptoms and side effects. All patients will have urine tests to test for drug abuse. An individual may be eligible for this study if he/she: Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years old.
NCT00000377 Preventing the Return of Depression in Elderly Patients Completed National Institute of Mental Health (NIMH) N/A The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant. This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
NCT00000377 Preventing the Return of Depression in Elderly Patients Completed University of Pittsburgh N/A The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant. This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.
NCT00000378 Antidepressant Treatment of Melancholia in Late Life Completed National Institute of Mental Health (NIMH) Phase 4 The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nortriptyline Hydrochloride

Condition Name

Condition Name for Nortriptyline Hydrochloride
Intervention Trials
Depression 9
Major Depressive Disorder 2
Chronic Pain 2
Gastroesophageal Reflux Disease 2
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Condition MeSH

Condition MeSH for Nortriptyline Hydrochloride
Intervention Trials
Depression 14
Depressive Disorder 11
Depressive Disorder, Major 6
Disease 4
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Clinical Trial Locations for Nortriptyline Hydrochloride

Trials by Country

Trials by Country for Nortriptyline Hydrochloride
Location Trials
United States 65
Germany 4
Brazil 3
Switzerland 2
Canada 2
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Trials by US State

Trials by US State for Nortriptyline Hydrochloride
Location Trials
Pennsylvania 6
California 5
New York 5
Missouri 5
North Carolina 4
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Clinical Trial Progress for Nortriptyline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Nortriptyline Hydrochloride
Clinical Trial Phase Trials
Phase 4 15
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Nortriptyline Hydrochloride
Clinical Trial Phase Trials
Completed 23
Recruiting 7
Unknown status 3
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Clinical Trial Sponsors for Nortriptyline Hydrochloride

Sponsor Name

Sponsor Name for Nortriptyline Hydrochloride
Sponsor Trials
National Institute of Mental Health (NIMH) 6
VA Office of Research and Development 4
University of Washington 3
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Sponsor Type

Sponsor Type for Nortriptyline Hydrochloride
Sponsor Trials
Other 43
NIH 12
U.S. Fed 11
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