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 chlordiazepoxide and amitriptyline 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. Chlordiazepoxide and amitriptyline 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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SUMMARY
CHLORDIAZEPOXIDE and AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP
Chlordiazepoxide and Amitriptyline Hydrochloride tablets combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant.
Chlordiazepoxide and amitriptyline hydrochloride is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.
The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone.
Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
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NEWS HIGHLIGHTS
Published Studies Related to Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline)
Clinical experience in the therapy of bites from exotic snakes in Berlin. [1992.11]
Since there are nearly no indigenous poisonous snakes in Germany, snake bites by poisonous snakes are rare... Despite serious coagulopathy in two of the patients and respiratory arrest in one, all survived without sequelae.
Clinical Trials Related to Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline)
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation [Completed]
This study aims mainly to investigate the effects of two approaches to control blood pressure
in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume
control (by strict dietary salt restriction and persistent ultrafiltration) without using
antihypertensive drugs on cardiac structure and inflammation.
Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data [Completed]
The majority of asthma patients are not well controlled, despite the availability of asthma
medication that could effectively treat the disease. In this study uncontrolled patients who
are steroid-naive or on low dose inhaled corticosteroids will be treated with
Salmeterol/Fluticasone combination (SFC) 50/250 µg bd. The asthma control test (ACT) will be
used to detect differences in the level of asthma control during treatment. The study aims to
show a correlation between improvements of ACT und the level of asthma control which will be
reached by the patients.
The aim of the study is to show that most of symptomatic asthma patients can reach 'well
controlled asthma' with SFC. We get information about ACT in daily practice and physicians
are trained to use the asthma control test as a screening tool and for follow up of asthma
management. Correlations are expected between the improvements in ACT, Quality of Life and
asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study [Recruiting]
In a prospective and randomized study protocol, three different blood pressure regulating
agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect
on the cerebral oxygen balance between both hemispheres during aortic coarctation repair.
Cerebral and somatic saturation will be monitored non-invasively and continuously via
optical sensors applied to the right and left forehead and the somatic regions. Arterial
blood pressure, central venous pressure, heart rate and systemic saturation will be recorded
continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6
definite time intervals. The study ends at the end of the operation.
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes [Recruiting]
This study in Germany is designed to compare the effects of twice-daily exenatide plus
metformin and twice-daily premixed human insulin aspart plus metformin with respect to
glycemic control, as measured by HbA1c, combined with the percentage of patients with at
least one treatment-emergent hypoglycemic episode. Patients will be treated with study
therapy for approximately 26 weeks.
Effect of Metformin in Patients With Type-1 Diabetes With Inadequate Glycaemic Control by Insulin and Diet
Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in
the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important
risk-factor for development of these late-diabetic complications. The Diabetes Control and
Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the
development and progression of these late-diabetic complications. Until now treatment with
insulin- and diet-therapy has been the only treatment-modalities available to improve the
glycaemic control in patients with type-1-diabetes. A substantial number of these patients
still have long-standing poor glycaemic control despite intensive treatment with insulin- and
diet-therapy.
The antidiabetic drug metformin has shown to be able to improve the glycaemic control in
combination with insulin and furthermore reduce both mortality and the risk of developing
cardiovascular disease in patients with type-2-diabetes.
Only few small studies have investigated the effect of treatment with metformin in patients
with type-1-diabetes. These studies have suggested a positive effect of metformin in these
patients too.
Method:
100 patients with type-1-diabetes with persistent poor glycaemic control i. e. HbA1c > 8. 5%
during the last 12 months are eligible. Patients are treated for one month with placebo.
Hereafter half of the patients will be treated with metformin and the other half continues
with placebo for 12 months both as add-on therapy. All patients are continuing ongoing
treatment with insulin throughout the study. Before and after the start of treatment with
metformin the effect on glycaemic control and other known risk-factors for development of
cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion,
endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.
This study will show if treatment with metformin can improve the glycaemic control and hereby
the prognosis of patients with type-1-diabetes with persistent poor glycaemic control despite
intensive treatment with insulin- and diet-therapy. This group of patients suffers the
highest risk of developing late-diabetic complications with reduced quality of life and
life-expectancy as a consequence.
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Page last updated: 2006-01-31
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