Recombinant interferon alpha-2b in paranoid schizophrenia.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000067

Enrollment

Registered

2009-02-11

Start date

1999-12-05

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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,

Interferon-alpha

Homeosycosics

Injections, Intramuscular

Placebos

recombinant human alpha-2b interferon

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Cuba

Contacts

Public ContactPedro Lopez Saura

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

lopez.saura@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026