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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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