Discontinuation of Antidepressant Medication in Primary Care.

Antidepressants Clinical Trial

Official title:

Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361514
• Other study ID #: MFN-ADM-2015-2019
• Secondary ID: NL56937.091.16
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Description:

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Methods/Design This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having received prescriptions for antidepressants in primary care for at least the past nine months

Exclusion Criteria:

• Current treatment by a psychiatrist

• Current diagnosis of substance use disorder

• Non-psychiatric indication for long-term antidepressant usage (i.e. neuropathic pain)

• Having participated in a mindfulness training (> 3 sessions) within the last 5 years

• Inability to perform the assessments due to cognitive or language difficulties

• Younger than 18 years

Related Conditions & MeSH terms

• Antidepressants

Intervention

Behavioral:
• Supported Protocolized Discontinuation (SPD)
Patients who choose to discontinue their medication will make a personal tapering schedule with their GP based upon a discontinuation protocol with tapering suggestions. The protocol offers suggestions to taper within a maximum of 6 months describing all types of available dosages per antidepressant so individualized schedules can be constructed. In addition, they will be offered supportive meetings with the GP's mental health assistant. The assistant will receive basic information about discontinuation guidance, i.e. the information brochure, decision aid, discontinuation protocol and a short guideline how to organise consultations.
• Mindfulness Based Cognitive Therapy (MBCT)
In addition to the SPD patients are offered Mindfulness Based Cognitive Therapy (MBCT) in homogeneous groups of patients willing to withdraw from their medication. MBCT will be offered according to the treatment protocol developed for recurrent depression, adaptated to the specific needs of patients discontinuing their antidepressant medication. The mindfulness courses will be provided by teachers qualifying the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders. All teachers will receive additional training in using the specific study protocol at the start of the project.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Innovatiefonds Zorgverzekeraars, Pro Persona

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness	Health service receipt self-report measure designed for economic evaluations in the Netherlands	baseline and 6, 9 and 12 months
Other	Euro-Quality of Life 5D-5L	Short self-report instrument to assess quality adjusted life years	baseline and 6, 9 and 12 months
Primary	Number of patients who fully discontinued their antidepressant medication after 6 months.	Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Use of medication will be measured with daily calendars. Patients daily fill out paper calendars describing their daily milligrams of their antidepressant use.	6 months
Secondary	Structured Clinical Interview for DSM-IV-TR Disorders	Diagnostic instrument to assess relapse of depressive episode	baseline and 6, 9 and 12 months
Secondary	Discontinuation-Emergent Signs and Symptoms	Self-report measure for assessing signs and symptoms associated with discontinuation or interruption of SSRI treatment.	baseline and 6, 9 and 12 months
Secondary	Inventory of Depressive Symptomatology	A clinican-administered interview assessing the severity of depressive symptoms	baseline and 6, 9 and 12 months
Secondary	State/Trait Anxiety Inventory	Self-report measure for assessing both state and trait levels of anxiety	baseline and 6, 9 and 12 months
Secondary	Module Suicide Cognitions of the Mini International Neuropsychiatric Interview	A clinican-administered interview assessing the suicidal cognitions and to specify suicidal risk	baseline and 6, 9 and 12 months
Secondary	Mental Health Continuum - short form	Self-report questionnaire that assesses emotional, psychological and social well-being	baseline and 6, 9 and 12 months
Secondary	Five Facet Mindfulness Questionnaire	Self-report measure assessing mindfulness skills	baseline and 6, 9 and 12 months
Secondary	Self-Compassion Scale	Self-report measure consisting of 12 items addressing six components: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification	baseline and 6, 9 and 12 months