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The effect of agomelatine on positive and negative symptoms of schizophrenic patients

Evaluating the effect of agomelatine on positive and negative symptoms of schizophrenic patients admitted to the psychiatry ward of Golestan hospital

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240805062662N1
Enrollment
22
Registered
2024-08-31
Start date
2024-09-05
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: In addition to the prescribed antipsychotic treatment that they were already taking, patients receive agomelatine tablets (Tadbir Kalaye Jam Pharmaceutical Company)

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with schizophrenia based on DSM-5 criteria Calgary Schizophrenia Depression Score (CDSS) = 18 PANSS positive symptoms subscale score is greater than 7 and less than or equal to 28. PANSS negative symptoms subscale score greater than or equal to 24 and at least 2 of the 3 main symptoms (emotional boredom, passive/indifferent social withdrawal and lack of spontaneity and fluency in conversation) have = 4 points.

Exclusion criteria

Exclusion criteria: Taking typical antipsychotic drugs, antidepressants, sodium valproate, lithium, and benzodiazepines The presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders, bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder Current or past (past 6 months) diagnosis of severe personality disorders that would compromise the participant's ability to perform the study requirements. Hypersensitivity to agomelatine or any of the ingredients of the placebo

Design outcomes

Primary

MeasureTime frame
5-DSM. Timepoint: Before the intervention, 2 and 4 weeks after the intervention. Method of measurement: Interview.;CDSS. Timepoint: Before the intervention, 2 and 4 weeks after the intervention. Method of measurement: Interview.;PANSS. Timepoint: Before the intervention, 2 and 4 weeks after the intervention. Method of measurement: Interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Amirshekari

Ahvaz University of Medical Sciences

amirshekari.t@ajums.ac.ir+98 917 368 7265

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026