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 citalopram hydrobromide tablets 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. Citalopram hydrobromide tablets are 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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CITALOPRAM SUMMARY
Citalopram hydrobromide is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRI's or of tricyclic, tetracyclic, or other available antidepressant agents.
Citalopram Hydrobromide Oral Solution is indicated for the treatment of depression.
The efficacy of Citalopram Hydrobromide Oral Solution in the treatment of depression was established in 4 to 6 week controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The antidepressant action of Citalopram Hydrobromide Oral Solution in hospitalized depressed patients has not been adequately studied.
The efficacy of Citalopram Hydrobromide Oral Solution in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Citalopram Hydrobromide Oral Solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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NEWS HIGHLIGHTS
Published Studies Related to Citalopram
Impact of CYP2C19 phenotypes on escitalopram metabolism and an evaluation of pupillometry as a serotonergic biomarker. [2009.09]
PURPOSE: To investigate the impact of cytochrome P450 2C19 (CYP2C19) phenotypes on escitalopram metabolism and to evaluate pupillometry as a serotonergic biomarker... CONCLUSIONS: The CYP2C19 polymorphism affects escitalopram metabolism, but the difference does not justify dose adjustment. The puzzling results from pupillometry can be due to interplay between a central and a local serotonergic effect. Based on these results, pupillometry can not be recommended as a serotonergic biomarker.
Citalopram for continuation therapy after repetitive transcranial magnetic stimulation in vascular depression. [2009.08]
OBJECTIVES: The authors previously reported that repetitive transcranial magnetic stimulation (rTMS) produced a response rate of 39.4% among 62 patients with treatment resistant vascular depression. This study was undertaken to assess the outcome of continuation therapy to prevent relapse among these patients during 9 weeks after completion of rTMS... CONCLUSION: More effective methods are needed to treat elderly patients with treatment resistant vascular depression and to prevent relapse among treatment responders.
Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. [2009.07]
CONCLUSION: Gen-citalopram appeared to be bioequivalent to Celexa, whereas Novo-venlafaxine XR was not bioequivalent to Effexor XR. Consequently, the Novo-venlafaxine formulation released its active ingredient more rapidly and outside the acceptable norm. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00676039.
Quetiapine augments the effect of citalopram in non-refractory obsessive-compulsive disorder: a randomized, double-blind, placebo-controlled study of 76 patients. [2009.07]
CONCLUSIONS: The combination of quetiapine and citalopram was more effective than citalopram alone in reducing OCD symptoms in treatment-naive or medication-free OCD patients. TRIAL REGISTRATION: www.trialregister.nl Identifier NTR116.
Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. [2009.07]
CONCLUSIONS: In this study, escitalopram was effective and well tolerated in the treatment of depressed adolescents.
Clinical Trials Related to Citalopram
Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features [Completed]
Aims of Study:
The aims of this study are 1) to examine the clinical utility of escitalopram in patients
with major depression with atypical features; 2) to evaluate the tolerability of escitalopram
in major depression with atypical features.
Study hypothesis and objectives. This study is proposed as an open-label study to gather
pilot data to examine whether escitalopram has clinical utility in the treatment of major
depression with atypical features. Because of the exploratory nature of the design, no
specific study hypotheses can be generated regarding efficacy of the drug. Our primary
hypothesis is that the effect size of escitalopram in atypical depression will be similar to
the effect size of escitalopram in major depression, its FDA approved indication.
Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram
oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x
20 mg) dose administered under fed conditions.
Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram
oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x
20 mg) dose administered under fasting conditions.
Efficacy of Escitalopram in the Treatment of Internet Addiction [Completed]
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and
effective in treating problematic internet use.
Escitalopram as a Treatment for Pain in Polyneuropathy [Completed]
Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is
a relatively new drug used in the treatment of depression. Escitalopram’s action mechanism on
the brain suggests that escitalopram also may have an effect on neuropathic pain. This study
will test the efficacy of escitalopram in patients with painful polyneuropathy.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 18 ratings/reviews, Citalopram has an overall score of 6.72. The effectiveness score is 7.11 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Citalopram review by 43 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 20 mg taken once per day for the period of two months |
| Other conditions: | | anxiety |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I no longer felt depressed. I felt back to "my old self" and able to function normally in everyday activities. |
| Side effects: | | When I first began taking this medication I had urgent need to urinate throughout day and night. This effect went away after about a month of taking the medication. |
| Comments: | | I took one pill every morning. |
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| | Citalopram review by 22 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Depression |
| Dosage & duration: | | 20mg 2 months, 40mg 1 month taken 1 pill each morning for the period of 3 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I feel that the citalopram helps keep me calm. I no longer have mood swings as often. No longer feel the need to just stay at home bymyself. No longer want to leave work because of depressed moods. |
| Side effects: | | First 2 days wicked nasea. I do sweat more than usual. Trouble sleeping at times. |
| Comments: | | I started taking 20mg pills for a few months. I noticed that it would feel as though it was wearing off by 7pm or so. My doctor prescribed me up to 30mg for a week and then to 40mg for the rest of the month. Things seem better than on the 20mg. However I still get depressed at times and nothing seems to ever go right. Perhaps therapy will help which my doctor mentioned. Going to continue on the 40mg for a few more months and see if it helps if not I will make another apt at the doctor and see what she thinks weather we want to try and up the dose or try something different. |
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| | Citalopram review by 27 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | mood |
| Dosage & duration: | | 20mg taken 1 a day for the period of 2 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | none |
| Side effects: | | diahharea |
| Comments: | | i have taken this drug just like i was instructed to, bu it did absolutely nothing for me. i would not reccommend this for anyone. i have found no effectiveness from this drug at all. i think it is a useless pill that should be removed from the market!!!!!!!!!! |
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Page last updated: 2009-10-20
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