Condition category
Respiratory
Date applied
07/08/2007
Date assigned
21/04/2008
Last edited
18/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christian P Subbe

ORCID ID

Contact details

77 Brook Lane
Chester
LL13 7TD
United Kingdom
+44 (0)1978 291100
csubbe@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of Citalopram on Health status, anxiety and depression in patients with chronic Obstructive pulmonary disease: a pilot study

Acronym

ECHO

Study hypothesis

Chronic obstructive pulmonary disease (COPD) sufferers often experience a vicious circle of breathlessness and anxiety. These symptoms commonly lead to reduced physical activity, progressive loss of fitness, increasing social isolation and depression (which often goes undiagnosed). If this circle could be broken improved physical functioning and quality of life might result.

Ethics approval

Approval was granted by the North Wales Health Authority Research Ethics Committee in a letter dated 05/02/2003 following a meeting on 22/01/2003 of the LREC North East Wales

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Matching oral citalopram 20 mg and placebo, starting with half a tablet once per day for two weeks, then one tablet per day for the remaining weeks with monthly follow up for three months and a two week period of half a tablet per day prior to discontinuation of treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Citalopram

Primary outcome measures

Health-related quality of life measured using St Georges Respiratory Questionnaire, measured at baseline and at three months.

Secondary outcome measures

1. Depression and anxiety measured using the Hospital Anxiety and Depression Score (HADS), measured at baseline and at three months
2. Depression, anxiety measured using the Depression in Medical Illness, a 10-item questionnaire (DM-10), measured at baseline and at three months

Additionally at baseline, one month, two months and three months a structured side effect profile was checked.

Overall trial start date

01/08/2003

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of COPD
2. Clinical diagnosis of anxiety or depression
3. Adults of either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Severe ischaemic heart disease
2. On treatment for anxiety or depression
3. Terminal illness

Recruitment start date

01/08/2003

Recruitment end date

01/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

77 Brook Lane
Chester
LL13 7TD
United Kingdom

Sponsor information

Organisation

North East Wales NHS Trust (UK)

Sponsor details

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
+44 (0)1978 291100
csubbe@hotmail.com

Sponsor type

Government

Website

http://www.newalesnhstrust.org.uk/

Funders

Funder type

Government

Funder name

North East Wales NHS Trust (UK) - Research and Development Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes