- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03899285
Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders (CRY-MOOD)
Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders: a Pilot Study (CRY-MOOD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal-Est, Quebec, Canada, H1T 2M4
- GMF-U Maisonneuve-Rosemont hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Citalopram increase (group A)
At the end of the preparation phase, non-responders will be randomized to receive a pill of citalopram 20 mg and a capsule of citalopram 20 mg for a length of 14 days. The total dose of citalopram will be 40 mg once daily. Follow up will last 8 weeks in total. |
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.
|
PLACEBO_COMPARATOR: Placebo (group B)
At the end of the preparation phase, non-responders will be randomized to receive a pill of citalopram 20 mg and a capsule of placebo (a capsule without medication) for a length of 14 days. The total dose of citalopram will be 20 mg once daily. Follow up will last 8 weeks in total. |
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.
|
NO_INTERVENTION: Observational arm (group c)
Eligible patients to this arm are responders to citalopram. A diminution of at least 30% of the symptoms from baseline with the MADRS is required to enter this arm. At the end of the first phase, these patients will pursue their citalopram 20 mg for the rest of the study (=6 weeks). It's possible that in this group, the treatment approach may vary depending the physician. Follow up will last 8 weeks in total. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 :
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Recruitment rate
Time Frame: 8 weeks
|
Number of enrolled patients divided by total number of patients who meet the eligibility criteria.
|
8 weeks
|
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. |
8 weeks
|
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).
|
8 weeks
|
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. |
8 weeks
|
Length of interviews
Time Frame: 8 weeks
|
An average of all the interviews will be calculated (in minutes).
|
8 weeks
|
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 weeks
|
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. |
8 weeks
|
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. |
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marie-Claude Lefebvre, MD, GMF-U Maisonneuve-Rosemont hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 2018-1215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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