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Completed

NCT Number: NCT03899285

Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders

Major depressive disorder is a common mental disorder and the leading cause of disability worldwide. According to the Canadian Network for Mood and Anxiety Treatment, early improvement following an antidepressant treatment is correlated with response and remission. Escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed to favor early improvement. However, this has never been tested systematically in a controlled study involving major depressive disorder patients that are non-responders to their antidepressant treatment.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GMF-U Maisonneuve-Rosemont hospital

Montreal East, Quebec, H1T 2M4, Canada

About this study

The investigators sought to assess whether it is feasible to perform a prospective randomized controlled double-blind feasibility study with a 2 week run-in period and 3 parallel groups randomized controlled study using citalopram. Citalopram has physicochemical properties compatible with over-encapsulation and a has a simple titration that allows the study of early dose increase.. It is among the most prescribed antidepressant in the province of Quebec and at the Hospital Maisonneuve-Rosemont - University family medicine group (U-FMG).

Since establishment of a randomized controlled trial is complex and expensive, a feasibility design is appropriate to identify all the obstacles and to minimize sources of possible bias (recruitment, follow up, resources).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understand french or english
  • Primary diagnostic of major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders criteria (5th edition)
  • Prescription of citalopram
  • Citalopram started less than 4 days ago
  • Able to receive informed consent
  • Not participating to another study

Exclusion criteria

  • Pregnancy or breastfeeding
  • Unable to participate to follow-up
  • Hypersensitivity to citalopram or any component of the formulation
  • Known QT interval prolongation or congenital long QT syndrome
  • Hepatic impairment (Child Pugh A, B or C)
  • Renal impairment (Clcr < 30 ml/min)
  • Known cytochrome P450 2C19 poor metabolizers
  • History of non-response to citalopram
  • Head trauma or severe cognitive impairment
  • Substance-related and addictive disorders controlled less than 3 months or uncontrolled
  • Schizophrenia or psychotic disorder
  • Mixed depression
  • History of manic/hypomanic episodes
  • Use of prohibited drugs : monoamine oxidase inhibitors, cytochrome P450 2C19 inhibitors, drugs at risk of causing prolongation of the QT interval, cimetidine, pimozide and antidepressors taken for another psychiatric condition.

Treatment and study plan

Citalopram 20mg or 40 mg (phase 2)

Drug

For non-responders, a randomisation 1:1 was chosen. The group A will receive 40 mg and the group B will receive 20 mg once daily of citalopram for 14 days.

Primary outcomes

  1. Primary outcomes determined by the proportion of non-responders (< 30 % improvement on the MADRS) after 2 weeks of treatment and the proportion of non-responders randomized patients who completed the study.

    Time frame: 8 weeks

    The efficacy of treatment was assessed by the Montgomery and Asberg Depression Rating Scale (MADRS).Threshold for non-responders : < 30 % improvement on the MADRS between T2 and T0. This scale was completed by a trained assessor and measures the severity of depressive episodes in patients with mood disorders. The scale is in french and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.

    Criteria for success of the randomization and completion of the study :

    • Sample size target : 24 non-responders randomized patients
    • Proportion of non-responders after 2 weeks of treatment (T2) : ≥ 0.45 (number of non-responders after 2 weeks of treatment divided by the number of enrolled patients).
    • Proportion of non-responders randomized patients who completed the full course of treatment (8 weeks) : ≥ 0.65 (number of non-responders randomized patients who completed the study divided by the total number of enrolled patients).

Secondary outcomes

  1. Proportion of eligible subjects

    Time frame: 8 weeks

    Number of subjects who meet the eligibility criteria divided by the total number of patients referred to the study team.

  2. Recruitment rate

    Time frame: 8 weeks

    Number of enrolled patients divided by total number of patients who meet the eligibility criteria.

  3. Retention rate

    Time frame: 8 weeks

    Total number of patients who completed the full course of study divided by the number of enrolled patients.

    A descriptive analyse will be performed to identify the reasons of prematures departures.

  4. Adherence rate to treatment

    Time frame: 8 weeks

    Assessed with pill count reported to the research pharmacy at each follow-up in clinic (T2, T4, T6 and T8).

  5. Unblinding rate

    Time frame: 8 weeks

    Number of unblinded patients divided by the total number of enrolled patients.

    A descriptive analyse will be performed to identify the reasons of unblinding.

  6. Length of interviews

    Time frame: 8 weeks

    An average of all the interviews will be calculated (in minutes).

  7. Side effects reported to the assessors and measured by the Frequency, Intensity, and Burden of Side Effect Rating (FIBSER).

    Time frame: 8 weeks

    The side effects were reported to assessor and their gravity were measured by a self-administrated scale called the FIBSER.The FIBSER is composed of 3 questions and takes 3 distinct aspects : frequency, intensity and the burden of side effect on the quality of life. The scale was in french and has 3 questions, with an overall score ranging from 0 to 18 points. Higher score indicates a high side-effect burden that should be evaluated.

  8. Response curves for all patients according to the results from the MADRS.

    Time frame: 8 weeks

    Compare the clinical response following the increase of citalopram at 2 weeks (group A) or 4 weeks (group B) in non-responder patients according to the results from the Montgomery and Asberg Depression Rating Scale (MADRS) at T2, T4, T6 and T8.

    This scale was completed by a trained assessor and measures the severity of depressive episodes in patients with mood disorders. The scale is in french and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.

  9. Correlation between the results of Patient Health Questionnaire-9 (PHQ-9) and the MADRS at each follow-up (T2, T4, T6 and T8).

    Time frame: 8 weeks

    A pearson coefficient to describe the correlation (r) between the PHQ-9 and the Montgomery and Asberg Depression Rating Scale (MADRS) was chosen.

    The PHQ-9 is a questionnaire self-reported assessing the severity of the depression. The scale was in french and has 9 items, with an overall score ranging from 0 to 27 points. Higher score indicates more severe depression.

    The MADRS was completed by a trained assessor and measures the severity of depressive episodes in patients with mood disorders. The scale is in french and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression.

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders: a Pilot Study (CRY-MOOD)

Acronym: CRY-MOOD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2019
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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