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Citalopram Hydrobromide

This article explores the use of Citalopram Hydrobromide in various clinical trials. These studies primarily focus on bioequivalence testing of different formulations and investigating its potential therapeutic benefits in conditions such as autism, hot flashes, and anorexia nervosa. The trials aim to evaluate the drug’s effectiveness, safety, and optimal dosing strategies across different patient populations.

Table of Contents

What is Citalopram Hydrobromide?

Citalopram Hydrobromide is a medication that belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs). It is commonly known by its brand name Celexa[1]. SSRIs work by increasing the levels of a neurotransmitter called serotonin in the brain, which helps regulate mood, emotions, and other mental processes.

Medical Uses

Citalopram Hydrobromide is primarily used to treat various mental health conditions. Based on the clinical trials data, it has been studied for use in:

  • Major Depression: It is commonly prescribed for treating severe depressive symptoms[2].
  • Autism Spectrum Disorders (ASD): Citalopram has been studied for its potential to treat repetitive behaviors in children with autism[3].
  • Hot Flashes: Research has explored its effectiveness in managing hot flashes in postmenopausal women, particularly those with a history of breast cancer or those who cannot take estrogen replacement therapy[4].
  • Anorexia Nervosa: Studies have investigated its use in treating depression associated with anorexia nervosa[2].

Administration and Dosage

Citalopram Hydrobromide is available in various forms and dosages:

  • Tablets: Commonly available in 10mg, 20mg, and 40mg strengths[5][1].
  • Oral Solution: A liquid form (10mg/5ml) is also available, which may be easier for some patients to take[3].
  • Intravenous (IV) Administration: In some cases, particularly for hospitalized patients, Citalopram may be given intravenously[2].

The dosage can vary depending on the condition being treated, the patient’s age, and other factors. Always follow your doctor’s instructions regarding dosage and administration.

Bioequivalence Studies

Several studies have been conducted to compare different formulations of Citalopram Hydrobromide to ensure they are bioequivalent (meaning they have the same effect in the body). These studies typically compare generic versions of the drug to the brand-name version (Celexa) under various conditions:

  • Fasting Conditions: Studies have compared how the body absorbs and processes the drug when taken on an empty stomach[6].
  • Fed Conditions: Other studies have looked at how food affects the absorption of the drug[5].
  • Different Strengths: Bioequivalence has been studied for various strengths of the medication, from 10mg to 40mg tablets[1][5].

These studies help ensure that generic versions of Citalopram Hydrobromide work just as well as the brand-name version.

Side Effects and Safety

Like all medications, Citalopram Hydrobromide can cause side effects. Some of the potential side effects that have been monitored in clinical trials include:

  • Changes in mood or behavior
  • Anxiety and depression symptoms
  • Physical symptoms such as nausea, headache, or changes in appetite
  • Behavioral activation (increased energy or restlessness)[3]

It’s important to report any side effects to your healthcare provider. They will monitor your response to the medication and may adjust the dosage if needed.

Use in Special Populations

Research has been conducted on the use of Citalopram Hydrobromide in specific populations:

  • Children with Autism: Studies have explored its potential benefits for repetitive behaviors in children with autism spectrum disorders[3].
  • Postmenopausal Women: Research has investigated its effectiveness for managing hot flashes in postmenopausal women, particularly those with a history of breast cancer[4].
  • Patients with Anorexia Nervosa: Studies have looked at its use in treating depression associated with anorexia nervosa[2].

Ongoing Research

Researchers continue to study Citalopram Hydrobromide to better understand its effects and potential uses. Some areas of ongoing research include:

  • Biomarkers for Treatment Response: Scientists are investigating whether certain biological markers can predict how well a person with anorexia nervosa and depression will respond to Citalopram treatment[2].
  • Different Administration Methods: Studies are comparing the effectiveness of oral versus intravenous administration of Citalopram[2].
  • Genetic Factors: Research is exploring how genetic variations might affect a person’s response to Citalopram[4].

These ongoing studies aim to improve our understanding of Citalopram Hydrobromide and optimize its use in treating various conditions.

Aspect Details
Drug Name Citalopram Hydrobromide
Brand Names Celexa
Study Types Bioequivalence, Efficacy, Safety
Conditions Studied Autism Spectrum Disorders, Hot Flashes, Anorexia Nervosa with Depression
Dosage Forms Tablets, Oral Solution, Intravenous
Dosage Strengths 10 mg, 20 mg, 40 mg
Study Designs Randomized, Crossover, Placebo-controlled
Primary Outcomes Bioequivalence parameters, Symptom reduction, Changes in biological markers
Population Healthy adults, Children with autism, Postmenopausal women, Patients with anorexia nervosa

FAQ

  • What is Citalopram Hydrobromide? Citalopram Hydrobromide is a medication commonly known by its brand name Celexa. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs) and is primarily used to treat depression and other mental health conditions.
  • What is the purpose of bioequivalence studies for Citalopram Hydrobromide? Bioequivalence studies compare different formulations of Citalopram Hydrobromide to ensure that generic versions of the drug are as effective as the brand-name version. These studies measure how the body absorbs and processes the drug under various conditions, such as with or without food.
  • What conditions are being studied for potential treatment with Citalopram Hydrobromide? The clinical trials mentioned in this article investigate the use of Citalopram Hydrobromide for various conditions, including autism spectrum disorders with repetitive behaviors, hot flashes in postmenopausal women, and major depression in patients with anorexia nervosa.
  • How is Citalopram Hydrobromide administered in these trials? The drug is administered in various forms depending on the study. Some trials use oral tablets, while others use liquid formulations. The dosages and administration schedules vary based on the specific trial and condition being studied.
  • What are some of the outcomes being measured in these clinical trials? The trials measure various outcomes, including bioequivalence parameters (such as maximum concentration and area under the curve), changes in specific symptoms (like hot flashes or repetitive behaviors), safety profiles, and changes in biological markers such as serotonin and dopamine levels.

Ongoing Clinical Trials on Citalopram Hydrobromide

  • Study on the Effectiveness of Hypothalamic Phospholipids and Citalopram for Treating Major Depressive Disorder in Elderly Patients

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Testing a Pharmacogenetic-Guided Treatment Selection Strategy with Antidepressant Drug Combination for Patients with Depressive Disorder

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Temporarily Stopping Duloxetine, Sertraline, and Paroxetine in Patients with Hip or Knee Osteoarthritis Undergoing Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Bioequivalence: The property of two drug products having the same active ingredient, dosage form, strength, and route of administration to be pharmaceutically equivalent and to have the same rate and extent of absorption when administered under similar conditions.
  • Cmax: The maximum concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.
  • AUC (Area Under the Curve): A measure of the total exposure to a drug over time, calculated by plotting drug concentration in the blood against time.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare with the active drug or treatment being studied.
  • Randomized: A study design where participants are assigned by chance to different treatment groups, reducing bias in the results.
  • Crossover study: A type of clinical trial where participants receive a sequence of different treatments over time, allowing each person to serve as their own control.
  • Fasting condition: A state where a person has not eaten for a specified period, usually overnight, before taking a medication or undergoing a medical test.
  • Fed condition: A state where a person has eaten a meal before taking a medication, used to study how food affects drug absorption.
  • Selective Serotonin Reuptake Inhibitor (SSRI): A class of antidepressant medications that work by increasing levels of serotonin in the brain.
  • Autism Spectrum Disorder (ASD): A developmental disorder characterized by difficulties with social interaction, communication, and repetitive behaviors.

References

  1. https://clinicaltrials.gov/study/NCT00865943
  2. https://clinicaltrials.gov/study/NCT05795283
  3. https://clinicaltrials.gov/study/NCT00086645
  4. https://clinicaltrials.gov/study/NCT00363909
  5. https://clinicaltrials.gov/study/NCT01149980
  6. https://clinicaltrials.gov/study/NCT01149967