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 Celexa 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. Celexa 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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CELEXA SUMMARY
Celexa® (citalopram HBr) is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents.
Celexa (citalopram HBr) is indicated for the treatment of depression.
The efficacy of Celexa in the treatment of depression was established in 4-6 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 Celexa in hospitalized depressed patients has not been adequately studied.
The efficacy of Celexa 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 Celexa 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 Celexa (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 Celexa (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, Celexa has an overall score of 6.56. The effectiveness score is 7.67 and the side effect score is 6.89. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Celexa review by 27 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Panic disorder |
| Dosage & duration: | | 20 mg/day taken daily for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | birth control | | |
Reported Results |
| Benefits: | | I had debilitating panic attacks and agoraphobia and Celexa completely saved me, allowed me to go live my life again. I even took a low dose and it still worked amazingly well, though it did take nearly a month to "kick in." |
| Side effects: | | In the beginning I had nightmares and some nausea, but that all passed within a few weeks. When I stopped taking the medication, I did suffer some side effects. |
| Comments: | | I took 20/mg a day each day for some number of years. |
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| | Celexa review by 34 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | anxiety & depression |
| Dosage & duration: | | 60mg taken lx/day for the period of 1 year |
| Other conditions: | | none |
| Other drugs taken: | | wellbutrin | | |
Reported Results |
| Benefits: | | helped improve mood, and made me more sociable and able to participate in treatment |
| Side effects: | | anorgasmia, zombie-like effect |
| Comments: | | I took 60mg for severe depression & anxiety. However, after 1 year, I decided to quit taking due to the sexual side effects. So far I just take wellbutrin for depression & am doing well. |
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| | Celexa review by 38 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 40mg. daily taken once daily for the period of 6 months |
| Other conditions: | | anxiety |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I took Celexa for approximately 6 months and I found it to be totally ineffective. This was not surprising considering I have taken several other psychotropic (SSRI's) drugs, with the same ineffectiveness. I'm finally thinking mabye I don't have a serotonin deficiency, and mabye there are other issues. Going back to dr. to see if there may be another course of action. |
| Side effects: | | sexual side effects, yawning, dry mouth |
| Comments: | | 40mg. daily for 6 months. |
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Page last updated: 2009-10-20
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