Academic trial of sertraline in depression

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000128
• Date of registration: 25/05/2012
• Primary sponsor: Dalhousie university, Halifax, Nova Scotia, Canada
• Public title: Academic trial of sertraline in depression
• Scientific title: "Evaluation of the effect and safety of sertraline in Cuban patients with major depressive disorder."
• Date of first enrolment: 11/05/2005
• Target sample size: 82
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000128-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Yudexi Mendoza Garcia
• Affiliation: National Coordinating Center of Clinical trials (CENCEC)

• Name: Yenia Sotolongo Garcia
• Affiliation: 10 de Octubre hospital

Key inclusion & exclusion criteria

Inclusion criteria: Pre-inclusion criteria Patients with major depressive disorder, diagnosed by DSM-IV. Patients with a value in the Hamilton Rating Scale for Depression (HAM-D) between 19 and 36 points inclusive. Patients of both sexes between 18 and 65, inclusive. Patients with capacity to consent for give their written consent to participate. 5. HCG (chorionic gonadotropin hormone) negative (for women of childbearing age). Inclusion criteria Patients whose score on the HAM-D at the end of the week pre-inclusion: • Do not change or, • Decrease less than 25% without being less than 19 points or, • It increases without exceeding 36 points. On the basis of physical examination, medical history, ECG, and the results of the tests: - Chemical Hematology: hemoglobin, hematocrit, total leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count, creatinine, glucose, albumin, total bilirubin, alkaline phosphatase, SGPT and SGOT and cituria conducted in the pre-inclusion visit, the patient is, in the opinion of the investigator and according to normal laboratory healthy enough to enter the study.
Exclusion criteria: Psychiatric treatment of patients with minimal therapeutic dose in the two months prior to inclusion (depot neuroleptics, antidepressants, lithium, or carbamazepine valproates). Presence of other psychiatric disorder diagnosed or referred that explain the Depression: Bipolar Disorder, Schizophrenia or Mental Retardation. Patients at risk of suicide or attempted suicide in the last year or with scores between 3 and 4 in the suicide item of HAM-D. Patients with mental disorders due to brain injury or dysfunction or somatic illness. Patients with mental and behavioral disorders due to psychoactive substance use (alcohol, drugs, multiple drugs or other substances). Patients with altered renal or hepatic function. Pregnant women, nursing mothers, pregnant or not using effective contraception [IUDs in use at least 30 days before the start of the study, barrier methods (diaphragm plus spermicide, condom plus spermicide) to use at least 14 days before the start of the study or hormonal methods (oral contraceptives, implants)]. Patients resistant to treatment with the use of 2 or 3 SSRIs, MAOIs or TCAs at doses established and during the stipulated time. Patients requiring further treatment with use of psychotropic drugs, psychotherapeutic techniques such as general psychotherapy, cognitive-behavioral techniques, predisposition modification techniques, psychotherapy or other specific technical brief psychotherapy. Patients with hypersensitivity to sertraline. Patients who have failed to have been treated with sertraline on a previous occasion. Patients who have been participating in a clinical trial within 30 days prior to inclusion. Patients with unstable medical condition. Patients withconcomitant diseases requiring treatment with any of the following medications: MAOIs, lithium, warfarin, digitoxin, intravenous diazepam and tricyclic antidepressants.

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

major depressive disorder

Intervention(s)

Study Group: Sertraline, 50 mg daily (1 capsule) for 4 weeks by oral route. At the end of this period incremental doses of 50 mg every two weeks can be made, if HAM-D is not improved over 25% regarding the day of inclusion of the patient and until the maximum dose (200 mg is reached), unless that: - In the fourth week assessment or subsequent assessments the patient shows worsening of their symptoms - if in The sixth week the patient maintains stable symptoms over the time of inclusion. In both cases, study treatment will be discontinued and the patient will receive standard treatment at the discretion of the specialist. Control group: Placebo (identical presentation), in the same therapeutic regimen, maintaining similar considerations of the study group. Both groups will receive interventions of support on a weekly basis if required. The treatment will have a total duration of 10 weeks in both groups. After completing the 10 weeks of trial treatment, patients with clinical improvement continue treatment with a maintenance dose as the patient's progress, to complete a period of 6 months. Clinical improvement is considered for those cases that at the end of the study are classified into one of the following categories: remission, improvement or partial improvement above 25% reduction in HAM-D according to the day of inclusion.

Primary Outcome(s)

Changes in the score on the Hamilton Rating Scale for Depression (HAM-D). Measurement time: Pre-enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months

Secondary Outcome(s)

Changes in the score on the Clinical Global Impression scale (CGI). Measurement time: Days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Change in the score on the Sexual Dysfunction Scale of the Massachusetts General Hospital Days 0, 42, 70 and 6 months Weight (Kgs). Measurement time: Pre-enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Adverse Event (AE). Measurement time: Days 7, 14, 21, 28, 42, 56, 70 and 6 months -Type of EA (name of the AE) -Intensity of AE (mild, moderate, severe) -Severity of AE (Serious or not) -Duration of the AE (to be recorded over time) -Attitude to drugs (to be recorded if there were changes, dose modification, interruption or discontinuance of treatment) -Result of the AE (1 Cured, 2 Enhanced, 3 persistent,4 Sequelae) -Causal Relationship of the AE (definite, likely, probable, possible, unrelated, unknown) -Treatment indicated (treatment received by each patient for the AE occurred)

Secondary ID(s)

DALHOUSIE-2004-1

Source(s) of Monetary Support

Canadian international development agency (CIDA, Canada) National Coordinating Center of Clinical Trials (CENCEC, Cuba) Dalhousie university, Halifax, Nova Scotia, Canada

Secondary Sponsor(s)

National Coordinating Center of Clinical Trials (CENCEC)