Recombinant interferon alpha-2b in paranoid schizophrenia.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000067
• Date of registration: 11/02/2009
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City.
• Public title: Recombinant interferon alpha-2b in paranoid schizophrenia.
• Scientific title: Administration of human recombinant interferon alpha-2b in paranoid schizophrenia as adjuvant to neuroleptic therapy. Multi-center, randomized, double-blind controlled trial.
• Date of first enrolment: 05/12/1999
• Target sample size: 60
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000067-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: Dr. Pedro Antonio Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

• Name: Pedro Antonio Saura
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion criteria

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.

Age minimum: 15 years
Age maximum: 65 years
Gender: Both

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.

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

IG/IAI/EP/9801

Source(s) of Monetary Support

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