Exploratory trial of antidepressant therapy for dizziness

ISRCTN	ISRCTN80847419
DOI	https://doi.org/10.1186/ISRCTN80847419
Secondary identifying numbers	N0530147182

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 20/09/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Prof Irwin Nazareth
Scientific

Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7830 2394
Email	I.nazareth@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Not Specified
Scientific title
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(s)	Not provided at time of registration
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Citalopram
Primary outcome measure	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 study start date	01/06/2003
Overall study end date	31/05/2005
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	48-64 participants
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 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

England
United Kingdom

Study participating centre

Royal Free and University College Medical School

London
NW3 2PF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Central London Research Consortium (UK) NHS support funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan