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Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of protriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Protriptyline hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use )
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VIVACTIL SUMMARY
Protriptyline hydrochloride is an antidepressant agent.
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
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NEWS HIGHLIGHTSMedia Articles Related to Vivactil (Protriptyline)
Depression As Deadly As Smoking, But Anxiety May Be Good For You Source: Anxiety / Stress News From Medical News Today [2009.11.19] A study by researchers at the University of Bergen, Norway, and the Institute of Psychiatry (IoP) at King's College London has found that depression is as much of a risk factor for mortality as smoking.
At-Risk College Students Reduce HBP, Anxiety, Depression Through Transcendental Meditation Source: Anxiety / Stress News From Medical News Today [2009.11.18] The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Symptoms Of Depression Improved By Motivational "Women-Only" Cardiac Rehab Source: Depression News From Medical News Today [2009.11.18] Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart Association's Scientific Sessions 2009. Depression often co-occurs with heart disease and is found more often in women with heart disease than in men.
Telephone-Delivered Care For Treating Depression After CABG Surgery Appears To Improve Outcomes Source: Depression News From Medical News Today [2009.11.17] Patients who received telephone-delivered collaborative care for treatment of depression after coronary artery bypass graft surgery reported greater improvement in measures of quality of life, physical functioning and mood than patients who received usual care, according to a study in the November 18 issue of JAMA. The study is being released early online because of its presentation at an American Heart Association scientific conference.
Treating depression after surgery speeds recovery (Reuters) Source: Y! Health Depression News [2009.11.17] Reuters - A simple telephone intervention improved mood, physical functioning, and overall quality of life in patients who were depressed after heart bypass surgery, researchers reported in a late breaking clinical trial here at the American Heart Association Scientific Sessions 2009.
Published Studies Related to Vivactil (Protriptyline)
Effect of protriptyline, 10 mg daily, on chronic hypoxaemia in chronic obstructive pulmonary disease. [1995.03] A daily dose of 20 mg of protriptyline can improve daytime arterial blood gas tensions in chronic obstructive pulmonary disease (COPD)... Despite the low dose, anticholinergic side-effects occurred in most patients.
The use of protriptyline for respiratory failure in patients with chronic airflow limitation. [1990.07] Treatment of nocturnal hypoventilation in patients with restrictive chest wall disease and respiratory failure, results in improved daytime arterial blood gas tensions, increase in functional ability and longer survival. Success has been achieved with the use of protriptyline which reduces the duration of rapid eye movement (REM) sleep during which nocturnal hypoventilation occurs.
Effect of protriptyline on ventilatory responses to hypercapnia and asphyxia in normal subjects. [1989.09] A double-blind crossover study was undertaken to assess the effect of protriptyline on ventilatory responses in normal subjects. Seven subjects received in random order placebo, 10 mg and 20 mg protriptyline daily for 2 weeks... Mean HCVR and HVR following 10 mg and 20 mg protriptyline did not differ significantly from measurements on placebo, neither for the single dose study or after 2 weeks.
Role of protriptyline and acetazolamide in the sleep apnea/hypopnea syndrome. [1988.10] The role of drug therapy in the treatment of the sleep apnea/hypopnea syndrome is unclear. In a randomised, double-blind, placebo-controlled study, we investigated the value of 14-day therapy with protriptyline (20 mg daily) or acetazolamide (250 mg 4 times per day) on symptoms and on the frequency of apneas, hypopneas, arousals, and 4% desaturations in 10 patients with obstructive sleep apnea/hypopnea syndrome.
Protriptyline, chronic tension-type headaches, and weight loss in women. [1997.07] Twenty-five women with chronic tension-type headaches were treated with protriptyline for 3 months, with attention paid to days of monthly headaches before and while taking the medication, as well as change in weight and side effects. One patient stopped the medication because of side effects and 2 did not return for follow-up, yielding 22 patients...
Clinical Trials Related to Vivactil (Protriptyline)
Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Recruiting]
Reduction of volume of the hippocampus has been associated with major depression in many
studies. It has been suggested that antidepressants may protect against hippocampus volume
loss in humans associated with multiple episodes of depression and may also reverse the
reduction of volume caused by the depression. In addition, genetic markers for serotonin are
implicated with depression, and may be an indication of reduced response to antidepressant
treatments.
This study aims to enroll patients who are defined as having treatment resistant depression
(no remission after at least 2 treatments trials with an antidepressant). They will receive
an MRI scan at the initial visit and either 6 months after sustained remission or 12 months
after they enter the study for non-remitters. They will also be asked to give a blood sample
for genotyping. They will be matched by age and handedness to healthy volunteers with no
personal history of depression who will also receive an MRI scan and genotyping.
The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It
is anticipated that subjects will initially have smaller hippocampal volume but of those who
sustain remission, there will be a small increase in hippocampal volume. It is also
anticipated that specific genetic markers will be related to individuals response to
antidepressant treatments.
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Page last updated: 2009-11-19
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