Influence of the depression treatment with escitalopram in mild to moderate arterial hypertension

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-5tzcnw
• Date of registration: 05/11/2014
• Prospective Registration: No
• Primary sponsor: Marcello Finardi Peixoto
• Public title: Influence of the depression treatment with escitalopram in mild to moderate arterial hypertension
• Scientific title: Influence of the depression treatment with escitalopram in mild to moderate arterial hypertension
• Date of first enrolment: 01/03/2010
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-5tzcnw
• Study type: Intervention
• Study design: Clinical trial, randomized, parallel, double blind, two arms, phase 4.
• Phase: 4

Countries of recruitment

Brazil

Contacts

• Name: Marcello Finardi Peixoto
• Affiliation: Universidade Federal de São Paulo

• Name: Marcello Finardi Peixoto
• Affiliation: Marcello Finardi Peixoto

Key inclusion & exclusion criteria

Inclusion criteria: 18 to 65 years; arterial hypertension stage 1 or 2; major depressive disorder

Exclusion criteria: Liver insuficiency; cardiac insuficiency, renal insuficiency; secundary arterial hypertension; use of psycotropics; psychotic disorder; alcohol or substances disorder; suicide risk

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

essential (primary) hypertension; depressive episode, unspecified

F32.9

Intervention(s)

Active group: 15 persons with high pressure and depression received escitalopram until 20 mg/day for 8 weeks.
Control group: 15 persons with high pressure and depression received placebo until 2 capsules/day for 8 weeks.

Drug

D27.505.954.427.700.122.050

Primary Outcome(s)

Expected primary outcome:dyastolic arterial pressure times 0 to 4; diference in dyastolic arterial pressure between times 0 to 1 and 1 to 4.

Expected primary outcome: alteration in the follow parameters: systolic arterial pressure times 0 to 4, ; diference in systolic arterial pressure between times 0 to 1 and 1 to 4

observed outcome: there were no statistical difference of the dyastolic arterial pressure in the following parameters; beginning 79,1mmHg ±9,66 x 82,1mmHg ±9,79, p=0,41; second week 90,6mmHg ± 12,88 x 85,6mmHg ±9,15 p=0,22; fourth week 86,8mmHg ± 13,02 x 80,4mmHg ±13,71 p=0,2; sixth week 81,3mmHg ± 11,69 x82,0mmHg ±13,24 p=0,88; eight week 80,3mmHg ± 12,80 x 80,6mmHg ± 13,37 p=0,96; difference between beginning and second week 16,3mmHg ±14,54 x 7,1mmHg ± 11,85 p=0,065; difference between beginning and eight week 10,2mmHg ± 6,27 x 5,0mmHg ± 9,41, p=0,089.

Observed outcome: significative fall in the diference of the systolic arterial pressure between times 1 to 4(( ?t1-t4: 20,07± 13,45 mmHgx 9,43± 14,87 mmHg? p=0,04).

observed outcome: there were no statistical difference of the systolic arterial pressure in the following parameters; beginning 139,0mmHg±13,39 x 146,7±11,49 p=0,1; second week 155,4mmHg±16,74 x 153,8±12,44 p=0,77; fourth week 142,0mmHg±16,83 x 142,4±15,65 p=0,94; sixth week 138,1±17,27 x 145,0±14,90 p=0,25; eight week 135,3mmHg±16,40 x144,4mmHg ±13,15 p=0,1; difference between beginning and second week 16,3mmHg ±14,54 x 7,1 ±11,85 p=0,065.

Secondary Outcome(s)

Expected secundary outcome: alteration in cardiac frequency times 0,1,2,3,4.

Observed secundary outcome: cardiac frequency time 4 lower on escitalopram group than placebo:escitalopram 66,88 ± 9,62 bpm x placebo 74,19 ± 9,55 bpm, p= 0,04.

Source(s) of Monetary Support

Marcello Finardi Peixoto

Secondary Sponsor(s)

Marcello Finardi Peixoto