Academic trial of sertraline in depression

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

"Evaluation of the effect and safety of sertraline in Cuban patients with major depressive disorder."

Secondary indentifying numbers:

DALHOUSIE-2004-1

Issuing authority of the secondary identifying numbers:

National Coordinating Center of Clinical Trials(CENCEC)

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

05/04/2005

Reference number:

05.032.04B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Yenia Sotolongo Garcia, MD. 1st Degree Specialist in Psychiatry

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Centro Comunitario de Salud Mental de Guanabacoa, Nadia B. Espinosa Rodriguez, MD. 1st Degree Specialist in Psychiatry. Cienfuegos, Hospital CQ Gustavo Aldereguia Lima, Juan Rafael Cordero Jimenez, MD. 2nd Degree Specialist in Psychiatry.

Research ethics committees:

Centralized Etihcs committee, 14/02/2005

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

11/05/2005

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

65 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yudexi

Last Name:

Mendoza Garcia

Affiliation:

National Coordinating Center of Clinical trials (CENCEC)

Postal Address:

Call 19 No. 19910, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537 2728342

Email :

yudexi@cencec.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Yenia

Last Name:

Sotolongo Garcia

Affiliation:

10 de Octubre hospital

Postal Address:

Calzada 10 de Octubre No. 130 entre Alejandro Ramirez y Agua Dulce. Cerro

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

537 8776260

Email :

yudexi@cencec.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000128

Date of Registration in Primary Registry:

2012-05-25

Record Verification Date:

2012-05-15 20:00

Link to the spanish version:

Click here [3]