Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Irwin Nazareth

ORCID ID

Contact details

Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7830 2394
I.nazareth@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0530147182

Study information

Scientific title

Acronym

Study hypothesis

In primary care attendees with symptoms of dizziness and associated psychological symptoms, a) antidepressants and b) vestibular rehabilitation exercises reduces symptoms of dizziness when either treatment is delivered singly or together in a factional design. Prior to testing this hypothesis, in this study the researchers propose to conduct an exploratory trial in which they will examine the effects of varying doses of antidepressants, on the symptoms of dizziness amongst general practice attendees visiting their GP for this purpose.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Dizziness

Intervention

1. Low dose antidepressant (Citalopram) therapy and self-help leaflet
2. Full dose antidepressant (Citalopram) and self-help leaflet
3. A control group receiving no antidepressant treatment, but receiving self-help leaflet

Added 20/09/2013: this trial never took place as there was no sponsorship agreed.

Intervention type

Drug

Phase

Not Specified

Drug names

Citalopram

Primary outcome measures

The community prevalence of dizziness ranges from 16-35%. One quarter of such sufferers report chronic handicapping symptoms and psychological distress. There are currently no evaluations of treatment for dizziness in the community. This study is the first step in evaluating a treatment that has been previously examined in a hospital setting.
This study will provide:
1. Information on the acceptability and feasibility of using antidepressants for people with dizziness in primary care.
2. Estimates of the numbers of people with dizziness who can be recruited to the study from each practice and hence assist with planning in a main trial.
3. Information on people's preferences for each intervention.
4. Preliminary estimates of the effect on clinical, psychological and physical outcomes in people with dizziness in primary care treated with low dose or full dose of antidepressants, which will inform sample size calculations for a main trial.
In addition, the results of this study will allow the researchers to finalise their assessment and treatment schedule for people with dizziness in primary care.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2003

Overall trial end date

31/05/2005

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

GP attendees with acute symptoms of dizziness, vertigo, lightheadedness, dysequilibrium, presyncope, and other types of balance problems for more than 2 months, associated with associated psychological symptoms.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

48-64 participants

Participant exclusion criteria

1. Below 18 years old and above 85 years old
2. Too ill to take part (i.e serious physical illness or terminal disorder)
3. First episode of dizziness
4. Acute dizziness
5. Vetebrobasilar insufficiency
6. Cardivascular diagnoses
7. Severe neurological disorders

Recruitment start date

01/06/2003

Recruitment end date

31/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free and University College Medical School
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Central London Research Consortium (UK) NHS support funding

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