GENetic and clinical Predictors Of treatment response in Depression

ISRCTN	ISRCTN31345163
DOI	https://doi.org/10.1186/ISRCTN31345163
Secondary identifying numbers	G0200243

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Glyn Lewis
Scientific

Division of Psychiatry
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom

Phone	+44 0117 954 6796
Email	Glyn.lewis@bristol.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	GENPOD
Study objectives	We wish to identify genetic and clinical predictors of response to SSRIs and NaRIs in depressive illness. Hypotheses: 1. Those who are homozygous for the insertion allele polymorphism in the promoter region of the 5HT transporter who are allocated SSRIs will have an improved response compared to those on NaRIs. This also implies that those who are not homozygous will have reduced response on SSRIs compared to those on NaRIs. 2. Those who have more severe depressive disorders who are allocated NaRIs and less severe disorder allocated SSRIs will have a better response compared to the other two groups
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders
Intervention	1. Reboxetine 4mg bd 2. Paroxetine 20mg
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Reboxetine, Paroxetine
Primary outcome measure	Beck depression inventory total score (BDI) at 6 weeks adjusted for baseline BDI score.
Secondary outcome measures	Not provided at time of registration
Overall study start date	23/02/2004
Completion date	22/05/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	74 Years
Sex	Not Specified
Target number of participants	887 Added 18/08/09: recruitment ongoing
Key inclusion criteria	18-74 years with the more severe depressions in whom the GP and patient have already agreed that antidepressants should be prescribed. We will therefore only include those with a Clinical Interview Schedule - Revised (CIS-R) score of ≥20, a Beck Depression Inventory (BDI) score of ≥15 and a diagnosis of International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10) depressive episode F32 and F33 (from CIS-R).
Key exclusion criteria	Pregnant and breast feeding women, patients with psychotic illness, alchohol or substance abuse problems, patients with medical contraindications to Citalopram or Reboxetine. (June 2006: Exclusion criteria were provided as follows: Potential subjects who have taken antidepressant medication within 2 weeks, who cannot complete self-administered scales, who have a psychosis or major substance or alcohol abuse. The GP will exclude anyone who has medical contraindications or in whom participation in the trial is not appropriate.)
Date of first enrolment	23/02/2004
Date of final enrolment	22/05/2008

Division of Psychiatry

Bristol
BS6 6JL
United Kingdom

Medical Research Council (UK)
Government

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7670 5259
Email	clinical.trial@headoffice.mrc.ac.uk

Research council

Medical Research Council (MRC) (G0200243) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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?
Protocol article	protocol	22/05/2008		Yes	No
Results article	results	01/06/2011		Yes	No