Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Depression

Depressive Disorder

Depressive Disorder, Major

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Psychotropic Drugs

Anti-Dyskinesia Agents

Escitalopram

Citalopram

Antidepressive Agents

Dexetimide

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Participants received citalopram 20 mg tablet once or twice daily for 12 weeks.

Participants received one psychotherapy session weekly for 12 weeks.

20 mg tablet one or twice daily for 12 weeks

Psychotherapy

Cinto Segalàs, MD, PhD.

To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression

The BDI is a validated, self-reported instrument assessing the severity of depression. Scoring range 0-9 indicates minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.

The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.

Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.

Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.

Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.

fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.

The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.

Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).

The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).

Institut Català d'Oncologia

Hospital Universitari de Bellvitge

Psychiatrist at the Bellvitge University Hospital. Researcher at the Bellvitge Biomedical Research Institute (IDIBELL). Associate professor at the Clinical Sciences Department of the Barcelona University (UB).

Mood Disorders

Mental Disorders

Psychotic Disorders

Behavioral Symptoms

Central Nervous System Depressants

Mirtazapine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Anti-Anxiety Agents

Adrenergic Agents

Adrenergic alpha-2 Receptor Antagonists

Adrenergic alpha-Antagonists

Adrenergic Antagonists

Serotonin 5-HT3 Receptor Antagonists

Treatment with oral mirtazapine, dosed once daily, for 9 weeks, with starting dose of 7.5 milligrams (mg) daily up to 30mg daily.

Treatment with Citalopram, once daily, for 9 weeks, with dosages starting at 10mg once daily to 40mg once daily.

7.5mg by mouth once a day at night. If subject has not had a 50% or greater reduction in the PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable adverse effects, then the dose may be escalated first to 15mg by mouth every night and then to 30mg by mouth every night.

Citalopram 10mg by mouth once daily. If the subject has not had a 50% or greater reduction in PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable side effects, then the dose may be escalated first to 20mg by mouth every day and then to 40mg by mouth once a day.

Eliza Park, MD

This is a pilot study to test the hypothesis that the antidepressants mirtazapine and citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.

Major depressive disorder (MDD) is a debilitating illness associated with increased mortality and significant impairment in quality of life. The prevalence of MDD is particularly high in patients with cancer, as much as 38% in some studies.

The study of depression in cancer patients is particularly important, as these co-morbid illnesses can frequently complicate the management of each other. In addition to affecting quality of life, poorly controlled depression can affect cancer treatment adherence and can lead to poor treatment outcomes.

Depression can be challenging to diagnose in patients with cancer. A spectrum of depressive symptoms can be seen, ranging from appropriate sadness in response to a life threatening diagnosis, to a major depressive episode. The diagnosis is confounded by the symptoms brought on by the cancer and its treatment, such as fatigue, insomnia, anorexia, and pain. Medications commonly used in cancer patients such as narcotics, benzodiazepines, antihistamines, steroids, antibiotics, chemotherapy, and endocrine therapy can all lead to side effects that further confuse the picture. However, while challenging, evidence does suggest that a valid diagnosis of depression can be made in this patient population.

The current standard for diagnosing MDD is the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM-IV-TR), which was published in 2000 by the American Psychiatric Association. The diagnosis is made based on an interview between the patient and physician in which nine criteria are assessed, including depressed mood, anhedonia, weight loss or gain, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue, feelings of worthlessness or guilt, difficulty concentrating, and recurrent thoughts of death. In patients with cancer, the diagnosis of MDD is more often based on anhedonia and feelings of worthlessness, as depressed mood, weight fluctuation, and sleep disturbance can be symptoms of the underlying cancer itself. Once the diagnosis has been made, there are several tools which have been created and validated for the purpose of assessing the severity of depression and for following the severity over time. The tool we intend to use in this study is the PHQ-9.

Therapy for MDD in the general population includes both psychotherapy and pharmacological intervention. However, the optimal therapy of MDD in cancer patients remains uncertain. Very few placebo controlled trials have been performed in this population, and there is currently no uniformly accepted standard of care. Some of the evidence from studies in depressed but otherwise medically healthy patients may be applicable to cancer patients, but there are several factors which complicate the treatment of depression in this group. For example, the overlap of symptoms between depression and the underlying malignancy can confound the diagnosis, as discussed earlier. Simultaneous treatment of the underlying malignancy introduces adverse effects from surgery, chemotherapy, or radiation, as well as an increased likelihood of drug-drug interactions. Finally, co-morbid conditions such as cancer pain can contribute to the depression, requiring simultaneous therapy. As a result of these unique factors, the treatment of MDD in cancer patients cannot necessarily be approached using the standard recommendations for the general population.

There is scant evidence supporting the effectiveness of pharmacologic therapy in cancer patients with MDD. In the last 25 years only four placebo controlled trials have been published, and of these only two have shown a statistically significant improvement in depression scores with active treatment.

Additional studies are needed to evaluate some of the newer antidepressants within the cancer population and to assess whether this strategy of matching side effects to symptoms is beneficial.

Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer

A Pilot Study to Evaluate Individualized Choice of Antidepressant in Patients With Cancer

To determine the feasibility of this pilot study to recruit subjects, as measured by the number of individuals enrolled per month, such that the goal of the study is met in a timely manner.

To assess the short-term (9 week) outcome of mirtazapine or citalopram in cancer patients with major depressive disorder based on mean improvement in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression	NCT05063604	Breast Cancer Major Depressiv...	Citalopram Psychotherapy	18 Years - 75 Years	Hospital Universitari de Bellvitge
Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer	NCT01725048	Major Depressiv... Neoplasms	Mirtazapine Citalopram	18 Years -	UNC Lineberger Comprehensive Cancer Center
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression	NCT05063604	Breast Cancer Major Depressiv...	Citalopram Psychotherapy	18 Years - 75 Years	Hospital Universitari de Bellvitge

Spots Global Cancer Trial Database for citalopram

Every month we try and update this database with for citalopram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for citalopram

Every month we try and update this database with for citalopram cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for citalopram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.