The effect of memantine as an adjunctive therapy in mania in bipolar disorder

Evaluating the Efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250430065539N1

Enrollment

Registered

2025-06-02

Start date

2025-06-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Bipolar disorder manic episode. Manic episode

Interventions

Intervention 1: Intervention group:after completing the differential blood cell count test, they will continue to receive lithium and olanzapine as usual. However, they will also receive 5 mg of meman

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: bipolar disorder DSM-5 criteria for a current manic episode Outpatient or inpatient visits to hospitals and clinics covered by Shiraz University of Medical Sciences

Exclusion criteria

Exclusion criteria: pregnancy patients with renal failure patients with liver failure

Design outcomes

Primary

Measure	Time frame
Young Mania Rating Scale. Timepoint: Measurement of mania severity at study initiation (before intervention) and at 2, 4, and 6 weeks after treatment initiation. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Side effects. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of checking and recording side effects as a secondary outcome in follow-up are done at 2, 4 and 6 weeks after the start of the study. Method of measurement: Questionnaire.;The number of hospitalizations. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time periods of examining and recording the number of patient's hospitalization as a secondary outcome are at the beginning of the study. Method of measurement: Questionnaire.;Family history of psychiatric problems. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time periods of examining and recording the patient's family history of psychiatric problems as a secondary outcome is at the beginning of the study. Method of measurement: Questionnaire.;The neutrophil-to-lymphocyte ratio (NLR). Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of measuring the neutrophil-to-lymphocyte ratio (NLR) as a secondary outcome are at the beginning and week 6 of the study. Method of measurement: Complete Blood Count With Differential.;Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG). Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of cognitive evaluation of the neuropsychiatric unit	—

Measure

Time frame

Side effects. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of checking and recording side effects as a secondary outcome in follow-up are done at 2, 4 and 6 weeks after the start of the study. Method of measurement: Questionnaire.;The number of hospitalizations. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time periods of examining and recording the number of patient's hospitalization as a secondary outcome are at the beginning of the study. Method of measurement: Questionnaire.;Family history of psychiatric problems. Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time periods of examining and recording the patient's family history of psychiatric problems as a secondary outcome is at the beginning of the study. Method of measurement: Questionnaire.;The neutrophil-to-lymphocyte ratio (NLR). Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of measuring the neutrophil-to-lymphocyte ratio (NLR) as a secondary outcome are at the beginning and week 6 of the study. Method of measurement: Complete Blood Count With Differential.;Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG). Timepoint: In the study evaluating the efficacy and side effects of memantine as adjunctive treatment of manic episodes in bipolar disorders- Interventional - Randomized controlled clinical trial, the time points of cognitive evaluation of the neuropsychiatric unit

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayyeh Rahimi

Shiraz University of Medical Sciences

Somayyehrahimi@sums.ac.ir+98 71 3228 9601

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 19, 2026