Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR178; OOG00-020
Study information
Scientific title
Acronym
HOMiD
Study hypothesis
Antidepressant medication does not add any effect to usual consultations by general practitioners in patients with minor and mild-major depression
Ethics approval
Received from local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2002
Overall trial end date
01/05/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
181
Participant 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
Recruitment start date
01/01/2002
Recruitment end date
01/05/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre,
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
EMGO Institute (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 20 4448180
emgo@vumc.nl
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
The Health Care Insurance Board (CVZ) (Netherlands)
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18067659
Publication citations
-
Results
Hermens ML, van Hout HP, Terluin B, Adèr HJ, Penninx BW, van Marwijk HW, Bosmans JE, van Dyck R, de Haan M, Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial., BMC Med, 2007, 5, 36, doi: 10.1186/1741-7015-5-36.