Mild depression in primary care: do antidepressants add any effect to usual consultations?

ISRCTN	ISRCTN03007807
DOI	https://doi.org/10.1186/ISRCTN03007807
Secondary identifying numbers	NTR178; OOG00-020

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Hein Hout, van
Scientific

VU University Medical Centre
EMGO-Institute
Department of General Practice
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title
Study acronym	HOMiD
Study objectives	Antidepressant medication does not add any effect to usual consultations by general practitioners in patients with minor and mild-major depression
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Depression
Intervention	Patients were randomly assigned to four sessions of counselling during 3 months with (n=85) or without paroxetine (n=96). Both treatments were carried out by the patients own GP.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	paroxetine
Primary outcome measure	1. Severity of Depressive by MADRS (Montgomery Åsberg Depression Rating Scale) 2. Remission of depression by MADRS score<10
Secondary outcome measures	1. Quality of Live (Short Form 36) 2. Subjective depression (Beck Depression. Inventory) 3. Client Satisfaction Questionnaire 4. Direct and indirect costs
Overall study start date	01/01/2002
Completion date	01/05/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	181
Key inclusion criteria	1. Aged 18 years or over 2. Having 3-6 out of 9 depressive symptoms for at least 2 weeks for most days of the week, including at least one of the core symptoms sadness or loss of pleasure. Impairment by depressive symptoms in social, occupational or other important areas of functioning (minor depression=3-4 symptoms, mild-major depression=5-6 symptoms)
Key exclusion criteria	1. Current intake of antidepressants or receiving psychological therapy 2. Psychotic features 3. Alcohol or drug addiction 4. Loss of a loved one or significant other in the past six months 5. Pregnancy or breastfeeding 6. Inability to complete questionnaires because of language difficulties, illiteracy or cognitive decline 7. Not having a telephone
Date of first enrolment	01/01/2002
Date of final enrolment	01/05/2005

VU University Medical Centre,

Amsterdam
1081 BT
Netherlands

EMGO Institute (Netherlands)
Not defined

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Government

The Health Care Insurance Board (CVZ) (Netherlands)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/12/2007		Yes	No