A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial
Objectives: As glutamatergic system dysfunction is involved in bipolar depression pathophysiology, the glutamate receptor modulators such as Ketamine have been applied as complementary medication for mood stabilizers. While the treatment is currently just the intravenous injection of a single dose,...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Tehran University of Medical Sciences
2023-09-01
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| Series: | Iranian Journal of Psychiatry |
| Subjects: | |
| Online Access: | https://ijps.tums.ac.ir/index.php/ijps/article/view/2880 |
| _version_ | 1797674820568088576 |
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| author | Ali Talaei Farhad Farid Hoseini Meisam Mahdavi Maryam Salehi Asieh Karimani Fahimeh Afzaljavan |
| author_facet | Ali Talaei Farhad Farid Hoseini Meisam Mahdavi Maryam Salehi Asieh Karimani Fahimeh Afzaljavan |
| author_sort | Ali Talaei |
| collection | DOAJ |
| description |
Objectives: As glutamatergic system dysfunction is involved in bipolar depression pathophysiology, the glutamate receptor modulators such as Ketamine have been applied as complementary medication for mood stabilizers. While the treatment is currently just the intravenous injection of a single dose, and there is no robust conclusion on Ketamine effectiveness or its side effects in bipolar patients, this study aimed to consider single- and double-dose intravenous injections of Ketamine in bipolar patients compared to the placebo.
Method: In a randomized, double-blind controlled clinical trial, 30 patients diagnosed with bipolar I and II disorders according to DSM-IV-TR (SCID-I) were randomly divided into three groups: the first group received an intravenous injection of Ketamine (0.5 mg/kg) and placebo with a three-day interval, the second group received two doses of Ketamine (0.5 mg/kg) in the same interval, and the third group received two placebo injections. Patients were assessed for depression, anxiety, and mania at various time points, including before the injection, 60 minutes after the injection, on the first, third, fifth, seventh, and 14th day, as well as at the end of the first month using the Hamilton Depression Rating Scale, Beck Anxiety Inventory, and Young Mania Scale, respectively. Data were analyzed using ANOVA and Repeated measure tests.
Results: The mean age of patients was 36.8 ± 7.9 years, with 18 females (60%) and 12 (40%) males. Depression and anxiety showed significant differences in both the single- and double-dose Ketamine groups over time (P < 0.01). Moreover, mania displayed significant changes during the study time in the single- and double-dose Ketamine groups, as well as the in the control group. However, during the study time, there were no significant differences observed in depression, anxiety, and mania among the three groups (P = 0.198, P = 0.416, and P = 0.540, respectively). Patients did not indicate any side effects during the study.
Conclusion: Intravenous Ketamine administration may relieve depressive manifestations in bipolar patients. The findings suggest that a double dose of Ketamine does not lead to greater improvement than a single dose.
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| first_indexed | 2024-03-11T22:05:36Z |
| format | Article |
| id | doaj.art-22ebf4e08ae44eb3b8aad087ba64f1ff |
| institution | Directory Open Access Journal |
| issn | 1735-4587 2008-2215 |
| language | English |
| last_indexed | 2024-03-11T22:05:36Z |
| publishDate | 2023-09-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Psychiatry |
| spelling | doaj.art-22ebf4e08ae44eb3b8aad087ba64f1ff2023-09-25T05:55:44ZengTehran University of Medical SciencesIranian Journal of Psychiatry1735-45872008-22152023-09-01184A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical TrialAli Talaei0Farhad Farid Hoseini1Meisam Mahdavi2Maryam Salehi3Asieh Karimani4Fahimeh Afzaljavan5Psychiatry and Behavioral Science Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.Psychiatry and Behavioral Science Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.Psychiatry and Behavioral Science Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.Research Center for Patient Safety, Mashhad University of Medical Sciences, Mashhad, Iran AND Clinical Research Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.Clinical Research Development Unit, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Objectives: As glutamatergic system dysfunction is involved in bipolar depression pathophysiology, the glutamate receptor modulators such as Ketamine have been applied as complementary medication for mood stabilizers. While the treatment is currently just the intravenous injection of a single dose, and there is no robust conclusion on Ketamine effectiveness or its side effects in bipolar patients, this study aimed to consider single- and double-dose intravenous injections of Ketamine in bipolar patients compared to the placebo. Method: In a randomized, double-blind controlled clinical trial, 30 patients diagnosed with bipolar I and II disorders according to DSM-IV-TR (SCID-I) were randomly divided into three groups: the first group received an intravenous injection of Ketamine (0.5 mg/kg) and placebo with a three-day interval, the second group received two doses of Ketamine (0.5 mg/kg) in the same interval, and the third group received two placebo injections. Patients were assessed for depression, anxiety, and mania at various time points, including before the injection, 60 minutes after the injection, on the first, third, fifth, seventh, and 14th day, as well as at the end of the first month using the Hamilton Depression Rating Scale, Beck Anxiety Inventory, and Young Mania Scale, respectively. Data were analyzed using ANOVA and Repeated measure tests. Results: The mean age of patients was 36.8 ± 7.9 years, with 18 females (60%) and 12 (40%) males. Depression and anxiety showed significant differences in both the single- and double-dose Ketamine groups over time (P < 0.01). Moreover, mania displayed significant changes during the study time in the single- and double-dose Ketamine groups, as well as the in the control group. However, during the study time, there were no significant differences observed in depression, anxiety, and mania among the three groups (P = 0.198, P = 0.416, and P = 0.540, respectively). Patients did not indicate any side effects during the study. Conclusion: Intravenous Ketamine administration may relieve depressive manifestations in bipolar patients. The findings suggest that a double dose of Ketamine does not lead to greater improvement than a single dose. https://ijps.tums.ac.ir/index.php/ijps/article/view/2880Bipolar DisorderDepressive DisorderKetamineRandomized Controlled Trial |
| spellingShingle | Ali Talaei Farhad Farid Hoseini Meisam Mahdavi Maryam Salehi Asieh Karimani Fahimeh Afzaljavan A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial Iranian Journal of Psychiatry Bipolar Disorder Depressive Disorder Ketamine Randomized Controlled Trial |
| title | A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial |
| title_full | A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial |
| title_fullStr | A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial |
| title_full_unstemmed | A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial |
| title_short | A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial |
| title_sort | comparison between single and double dose intravenous ketamine administration in bipolar mood disorder a double blind controlled clinical trial |
| topic | Bipolar Disorder Depressive Disorder Ketamine Randomized Controlled Trial |
| url | https://ijps.tums.ac.ir/index.php/ijps/article/view/2880 |
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