Antidepressants for Anxious Depression
(DOTS-AD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Cincinnati
Must be taking:Escitalopram, Duloxetine
Disqualifiers: Intellectual disability, Suicide risk, Alcohol use, others
Stay on your current meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it excludes those taking medications that require a taper or washout period longer than 5 days.
What data supports the effectiveness of the drug for anxious depression?
Research shows that escitalopram, one of the drugs in the treatment, is effective in treating depression and anxiety symptoms. Additionally, escitalopram has shown significant effects in reducing anxiety in conditions like social anxiety disorder and generalized anxiety disorder.
12345Is citalopram or escitalopram safe for humans?
Citalopram and escitalopram are generally considered safe, but they have important safety considerations, such as potential heart-related side effects, especially in people with a history of fainting or poisoning. It's recommended to perform an electrocardiogram (a test that checks for heart problems) on elderly patients before starting these medications.
56789How do the drugs Duloxetine and Escitalopram differ from other treatments for anxious depression?
Duloxetine and Escitalopram are unique because they target both depression and anxiety symptoms, with Escitalopram showing rapid improvement in anxiety symptoms within the first week. Unlike some other antidepressants, they have fewer sedative effects, making them a preferred choice for treating anxiety symptoms in depression.
13101112Eligibility Criteria
This trial is for English-speaking adults aged 18-50 with anxiety and depression, confirmed by specific criteria and tests. They must have a certain score on the HAM-A scale, no significant health issues or drug use, not be pregnant or breastfeeding, and agree to reliable contraception.Inclusion Criteria
I use a vaginal ring or contraceptive implant for birth control.
I use skin patches or injections for birth control.
I am using or will use an approved method of birth control during and after the study.
I am between 18 and 50 years old.
My drug test at the first visit was negative.
I have been treated with escitalopram, citalopram, or duloxetine for at least 6 weeks.
I have been surgically sterilized.
I have been diagnosed with an anxiety disorder.
My physical exam and heart test results are normal.
I am currently using oral contraceptives.
Exclusion Criteria
I cannot swallow capsules.
I have a serious health condition.
Participant Groups
The study compares two antidepressants: Escitalopram and Duloxetine. It starts with one of these drugs chosen randomly. If symptoms persist, participants are then given either Clonazepam or Pregabalin in addition to their initial treatment.
2Treatment groups
Active Control
Group I: EscitalopramActive Control1 Intervention
Adaptively randomized, double-blind treatment with escitalopram for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with escitalopram or citalopram for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.
Group II: DuloxetineActive Control1 Intervention
Adaptively randomized, double-blind treatment with duloxetine for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with duloxetine for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.
Duloxetine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cymbalta for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
🇪🇺 Approved in European Union as Cymbalta / Yentreve for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia
- Stress Urinary Incontinence
🇨🇦 Approved in Canada as Cymbalta for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Cincinnati, Department of Psychiatry & Behavioral NeuroscienceCincinnati, OH
Loading ...
Who is running the clinical trial?
University of CincinnatiLead Sponsor
References
Anxiety does not predict response to duloxetine in major depression: results of a pooled analysis of individual patient data from 11 placebo-controlled trials. [2015]Uncontrolled antidepressant trials suggest that anxious patients with major depressive disorder (MDD) are less responsive to antidepressant treatment than less anxious patients. The objective of this study is to determine whether specific antidepressant effects, estimated by drug-placebo differences, are reduced in anxious depression during treatment of MDD with duloxetine.
Anxious depression: clinical features and treatment. [2021]Anxious depression has been conceptualized in at least two related but separate ways: 1) major depressive disorder with at least one comorbid Axis I anxiety disorder and 2) major depressive disorder with a high level of anxiety with or without one or more comorbid Axis I anxiety disorders. Using either definition, patients with anxious depression seem to have a more chronic course of illness, an increased incidence of suicidal thoughts and behavior, greater functional and occupational impairment, and poorer response to treatment. Multiple classes of medications are used to treat anxious depression, most commonly first- and second-generation antidepressants, atypical antipsychotics, and benzodiazepines. Certain patients with anxious depression may require lower starting doses, more gradual dose escalations, higher end point doses, longer duration of treatment, and/or early augmentation with other agents. Nonpharmacologic treatments such as targeted psychotherapy and preventative stepped-care approaches also may be effective. Well-conceived, randomized controlled treatment trials are necessary to make further gains in the management of patients with anxious depression.
Efficacy and Safety of Escitalopram, Desvenlafaxine, and Vortioxetine in the Acute Treatment of Anxious Depression: A Randomized Rater-blinded 6-week Clinical Trial. [2023]Anxious depression is associated with greater chronicity, higher severity of symptoms, more severe functional impairment, and poor response to drug treatment. However, evidence for first-choice antidepressants in patients with anxious depression is limited. This study aimed to compare the efficacy and safety of escitalopram, desvenlafaxine, and vortioxetine in the acute treatment of anxious depression.
Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. [2019]Citalopram is a racemic selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression. Citalopram is a racemate and its serotonin reuptake inhibitory activity resides primarily in the single S-isomer, escitalopram, which is now being evaluated for its potential usefulness in the treatment of depression and other psychiatric disorders. RESULTS from placebo-controlled studies that also included citalopram as an active control have shown that escitalopram is effective in treating depression and associated symptoms of anxiety. However, none of these studies was powered sufficiently to detect differences between active treatment groups. The goal of the present analysis is to evaluate the efficacy of escitalopram compared with citalopram in the treatment of major depressive disorder.
Escitalopram in the treatment of panic disorder: a randomized, double-blind, placebo-controlled trial. [2022]Escitalopram, the therapeutically active isomer of the racemic selective serotonin reuptake inhibitor antidepressant citalopram, has shown significant anxiolytic effects in placebo-controlled clinical trials of social anxiety disorder, generalized anxiety disorder, and anxiety symptoms associated with major depression. This study evaluated the safety and efficacy of escitalopram in outpatients diagnosed with panic disorder.
[Fluvoxamine in the treatment of depressive disorders in alcohol dependence: results of randomized open-label comparative study]. [2022]Assess the efficacy and safety of fluvoxamine, sertraline, citalopram, paroxetine, fluoxetine.
Citalopram versus mianserin. A controlled, double-blind trial in depressed patients. [2019]In a double-blind trial, comprising 60 endogenously depressed patients, citalopram was compared with mianserin. Fifty-eight patients completed the 6-week trial period with ratings and side effect recordings at weeks 0, 1, 2, 4, and 6. Both drugs were administered as a single evening dose, 20-80 mg (most frequently 40 mg) for citalopram and 60-120 mg (most frequently 90 mg) for mianserin. CPRS (Subscale for Depression) total scores showed a highly significant reduction in both groups with a significant difference in favour of citalopram after 1 and 2 weeks. Based on the Global Evaluation of the Severity of Illness there were 18 complete and three partial responders on citalopram and 13 complete and four partial responders on mianserin. Six patients on citalopram and one patient on mianserin showed mild or moderate side effects, but no cardiovascular side effects were recorded. The authors conclude that citalopram is a safe antidepressant drug, presumably better than mianserin.
[Citalopram, escitalopram and prolonged QT: warning or alarm?]. [2022]The alerts issued by regulatory agencies on the potential cardiac toxicity of citalopram and escitalopram have caused alarm among clinicians. A review of the data concerning this topic shows that the alarm should be limited to patients with a history of syncope or poisoning. As a precautionary measure, an electrocardiogram should be performed on elderly patients.
Safer citalopram use in primary care: Can staff education and prescribing prompts improve adherence to national guidance? A closed loop clinical audit, service evaluation and quality improvement study. [2023]Citalopram is a drug with many important safety considerations in prescribing including dosage adjustments, pre-prescription testing and multiple interactions. Because of this, the UK government issued advice regarding the prescription of citalopram and escitalopram in its Drug Safety Update Vol 5 Issue 5, Dec 2011,[1] and the expectation is that all prescribers adhere to this.
[The dynamics of anxious depression under the treatment with antidepressants with different mechanisms of action]. [2022]Peculiarities of the dynamics of anxious depression under the treatment with selective serotonergic antidepressants with different mechanisms of action on the serotonin reuptake were investigated. It was examined 61 patients with anxious depression (ICD-10 F32.1, F33.1, F34.1) treated with zoloft (sertraline) or coaxil (tianeptine) as a monotherapy. The following methods were used: clinical-psychopathological, psychometric (Hamilton Rating Scales for Depression and Anxiety, the Sheehan Patient-Related Anxiety Scale) and statistical analysis. The comparative investigation has shown that both zoloft and coaxil are practically equally effective in the treatment of anxious depression with some peculiarities in the dynamics of clinical parameters.
[Effects of escitalopram on anxiety symptoms in depression]. [2022]Selective serotonin reuptake inhibitors, the antidepressants most widely prescribed today, exert specific action against various anxiety disorders and have an excellent acceptability profile. In addition, anxiety problems are commonly seen in depression, in the form of either characterised anxiety disorders or associated anxious symptoms. Such symptoms of anxiety result in increased risk of suicide and appear to be associated with development of more severe and chronic depressive disorders. Because of the adverse effects associated with anxiolytics, in particular benzodiazepines, their indications have been restricted. Consequently, first-line drug therapy for anxiety symptoms associated with depression involves selection of an antidepressant having anxiolytic properties. Specific serotonin reuptake inhibitors are commonly favoured at present since they have a less pronounced sedative effect than the tricyclic antidepressants (e.g. amitriptyline, maprotiline). Escitalopram, the active enantiomer of citalopram, has demonstrated efficacy and rapidity of action upon depressive symptoms seen in major depressive episodes. Global analysis of three studies comparing citalopram and escitalopram with a placebo in depressive disorders allowed specific investigation of the activity of these molecules upon the anxiety component of depressive disorders. Anxiety was quantitatively evaluated using item 6 (inner tension) of the MADRS, and for two of the three studies, using the anxiety sub-score of the HAM-D as well as the HAM-A total score. The results for the two active molecules demonstrate significant superiority in comparison with the placebo. Furthermore, in the case of escitalopram, this improvement appeared significant as of the first week of treatment (p
An open, non-randomised comparison of escitalopram and duloxetine for the treatment of subjects with Generalized Anxiety Disorder. [2022]This study compares the effectiveness of a 6-months treatment with escitalopram (ESC), a selective serotonin reuptake inhibitor, or duloxetine (DUL), a balanced serotonin and nor-adrenaline reuptake inhibitor, in 43 subjects with Generalized Anxiety Disorder (GAD).