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

NCT ID: NCT03899285

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-12-08

Brief Summary

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.

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).

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Citalopram 20mg or 40 mg (phase 2)

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Citalopram 20mg or 40 mg (phase 2)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Citalopram 20mg or 40 mg (phase 2)

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Marie-Claude Lefebvre

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Claude Lefebvre, MD

Role: PRINCIPAL_INVESTIGATOR

GMF-U Maisonneuve-Rosemont Hospital

Locations

GMF-U Maisonneuve-Rosemont hospital

Montreal East, Quebec, Canada

Countries

Canada

Other Identifiers

2018-1215

Identifier Type: -

Identifier Source: org_study_id