Recombinant interferon alpha-2b in paranoid schizophrenia.

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:

Administration of human recombinant interferon alpha-2b in paranoid schizophrenia as adjuvant to neuroleptic therapy. Multi-center, randomized, double-blind controlled trial.

Secondary indentifying numbers:

IG/IAI/EP/9801

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biothecnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A. and the Cuban Ministry of Public Health (MINSAP).

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 :

11/06/1997

Reference number:

ERM: 304/97.

Principal investigator

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

First name:

Liuba

Midle name:

Last name:

Penna Galvan

Affiliation:

"Octavio de la Concepcion y de la Pedraja" Surgical Clinical Military Hospital

Postal address:

Cornelio Porro No 102 entre 3ra y 4ta Reparto Garrido

City:

Camaguey

País:

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:

Cienfuegos, "Gustavo Aldereguía Lima", Provincial Hospital; Odalys Fernández López.

Santiago de Cuba, Teaching-Surgical Hospital; Dulce María Mojena.

Matanzas, "Faustino Pérez", Provincial Hospital; Dr. Vicente Hernández Castro.

Ciego de Ávila, "Antonio Luaces", Provincial Hospital; Dr. María Luisa Ellis Yard.

Ciego de Ávila, “Roberto Rodríguez", Provincial Hospital, Morón; Dr. Mercedes Anechina González.

Pinar del Río, "Abel Santamaría", Provincial Hospital; Dr. Tomás Rodríguez López.

Havana City, "Hermanos Ameijeiras", Hospital; Dr. Iluminada Cedeño Zayas.

Havana City, "Julio Trigo", Hospital; Dr. Octavio Garciga Ortega.

Havana City, "Luis Díaz Soto", Institute of Military Medicine; Dr. René Ventura Velasquez.

Havana City, Community Center for Mental Health, Regla; Dr. Virginia M. Ramos Leo.

Havana City, "Dr. Carlos J. Finlay", Military Hospital; Dr. María Cardona.

Havana City, Clinic for Adolescents; Dr. Antonio Bandera Rosell.

Havana City, Pediatric Hospital, Cerro; Dr. Vivian Ravelo Pérez.

Havana City, Psychiatric Hospital; Dr. José Francisco Pérez Milán.

Research ethics committees:

ad hoc Review and Ethics Committee: July 24th1996.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

05/12/1999

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:

Paranoid Schizophrenia. Diagnosis of paranoid schizophrenia will be made according to the International Classification of Diseases (ICD-10), clinical descriptions and research guidelines, using the structured questionnaire System for Clinical Assessment in Neuropsychiatry (SCAN) as an interview and diagnosis instrument. The second part of the present status examination (PSE 10) will be taken. Diagnosis will be confirmed by the CATEGO-5 program. An acute term of the psychotic symptoms that lasts more than 7 days will be considered as an episode or relapse, undergoing a neuroleptic drug therapy or not.

Health condition(s) code:

Schizophrenia, Paranoid

Schizophrenia

Schizophrenia Spectrum and Other Psychotic Disorders

Mental Disorders

Intervention(s):

Group I: (Treatment). Schizophrenic patients, who will have high potency neuroleptic drug therapy and recombinant interferon alpha-2b (3 x 106 IU). The route of administration will be intramuscular, at a rate of 1 vial twice a week (the same days of the week), at least every three days, during 52 weeks. Group II: (Control). Schizophrenic patients, who will undergo high potency neuroleptic drug therapy and placebo. Placebo will be administered to the control group, following the same IFN administration schedule. It is a substance with similar appearance to the IFN vials except that differs in the absence of this active principle.

Intervention code:

Interferon-alpha

Homeosycosics

Injections, Intramuscular

Placebos

Intervention keyword:

recombinant human alpha-2b interferon

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):

Duration and intensity of the psychotic episodes, during the treatment term (1 year). The evaluation is carried out after a year.

Key secondary outcomes:

1. Amount of neuroleptic drugs needed during the maintenance period and the crises, after 6 months and one year of treatment. (The amount of the different neuroleptic drugs was homogenized to chlorpromazine milligram-equivalents). 2. Frequency of the psychotic episodes (crises), during the treatment period (1 year). The evaluation is carried out after 6 months and one year of treatment. 3. Proportion of patients without psychotic episodes, during treatment. The evaluation is carried out after 6 months and one year of treatment. 4. Clinical evaluation: positive symptoms, negative symptoms and global activity scales, after 6 and 12 months of treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

15 years

Maximum age:

65 years

Inclusion criteria:

1. Fulfillment of the diagnosis criteria. 2. Patients with 1-month-10-year term of the evolution of disease. 3.15-65 years-old. 4. Patient´s and/or legal guardian´s signed informed consent.

Exclusion criteria:

1. Schizophrenic patients with episodes. 2. Pregnancy or puerperium. 3. Use of any other treatment, which is not foreseen in the study that changes the development of the disease. 4. Women in fertile age, undergoing hormonal contraceptive therapy. 5. Uncompensated chronic sickness (heart failure, liver failure, renal failure, diabetes mellitus [DM]). 6. Autoimmune diseases. 7. Hypersensitivity to the IFN or other type of preparations used in the trial.

Type of population:

Children and 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:

2-3

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:

Pedro

Middle Name:

Antonio

Last Name:

Lopez Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087378, 2085887, 2087421, 2087465.

Email :

lopez.saura@cigb.edu.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:

Pedro

Middle Name:

Antonio

Last Name:

Lopez Saura

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087378, 2085887, 2087421, 2087465.

Email :

lopez.saura@cigb.edu.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:

RPCEC00000067

Date of Registration in Primary Registry:

2009-02-11

Record Verification Date:

2009-01-12 19:00

Link to the spanish version:

Click here [3]