Recombinant interferon alpha-2b in paranoid schizophrenia.

Phase 2

Registration Number: RPCEC00000067

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.