mianserin and Stress Disorders, Post-Traumatic studies

Mianserin: A tetracyclic compound with antidepressant effects. It may cause drowsiness and hematological problems. Its mechanism of therapeutic action is not well understood, although it apparently blocks alpha-adrenergic, histamine H1, and some types of serotonin receptors.
mianserin : A dibenzoazepine (specifically 1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine) methyl-substituted on N-2. Closely related to (and now mostly superseded by) the tetracyclic antidepressant mirtazapinean, it is an atypical antidepressant used in the treatment of depression throughout Europe and elsewhere.

Stress Disorders, Post-Traumatic: A class of traumatic stress disorders with symptoms that last more than one month.

Research Excerpts

Excerpt	Relevance	Reference
"Mirtazapine was introduced and quetiapine increased."	5.48	Severe rhabdomyolysis induced by quetiapine and mirtazapine in a French military soldier. ( Delacour, H; Keou, S; Lahutte, B; Mennessier, C; Ratnam, C; Saguin, E, 2018)
" A re-evaluation of its pharmacological treatment with the introduction of mirtazapine (30 mg/day) was associated with a rhabdomyolysis (CK> 20,000 IU/L at day 3)."	3.88	[Antipsychotic induced rhabdomyolysis]. ( Delacour, H; Keou, S; Lahutte, B; Mennessier, C; Plantamura, J; Ratnam, C; Saguin, E, 2018)
"There was no effect on PTSD symptoms, no effect of psychotherapy and no interaction between psychotherapy and medicine."	2.82	The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. ( Buhmann, CB; Carlsson, J; Ekstroem, M; Mortensen, EL; Nordentoft, M, 2016)
"Thirty-six adults with PTSD were randomized to 24 weeks of double-blind treatment with sertraline plus mirtazapine or sertraline plus placebo."	2.80	COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. ( Campeas, R; Carcamo, J; Glass, A; Lewis-Fernandez, R; Neria, Y; Sanchez-Lacay, A; Schneier, FR; Vermes, D; Wall, MM, 2015)
"Mirtazapine was more effective than placebo on some measures in posttraumatic stress disorder and general anxiety symptoms."	2.71	Mirtazapine vs. placebo in posttraumatic stress disorder: a pilot trial. ( Barnett, S; Butterfield, MI; Casat, CD; Connor, KM; Davidson, JR; van Meter, S; Weisler, RH, 2003)
"Mirtazapine appeared to be an effective and well-tolerated treatment for PTSD in Korean veterans."	2.71	Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial. ( Chung, MY; Jun, EM; Jun, YJ; Kim, SS; Kim, WC; Min, KH, 2004)
"Mirtazapine was administered for 8 weeks using a flexible-dose regime in 15 Korean patients with PTSD based on the DSM-IV criteria."	2.70	Effects of mirtazapine in patients with post-traumatic stress disorder in Korea: a pilot study. ( Bahk, WM; Chae, JH; Jun, TY; Kim, KS; Pae, CU; Tsoh, J, 2002)
"Mirtazapine was associated with clinical improvement in 50% of subjects with severe, chronic PTSD, suggesting a need for further investigation in double-blind, placebo-controlled trials."	2.69	A pilot study of mirtazapine in post-traumatic stress disorder. ( Ahearn, E; Connor, KM; Davidson, JR; Weisler, RH, 1999)
"Mirtazapine is an antidepressant with mode of action different from other currently available antidepressants."	2.40	Mirtazapine: other indications. ( Falkai, P, 1999)
"Mirtazapine was introduced and quetiapine increased."	1.48	Severe rhabdomyolysis induced by quetiapine and mirtazapine in a French military soldier. ( Delacour, H; Keou, S; Lahutte, B; Mennessier, C; Ratnam, C; Saguin, E, 2018)
"Posttraumatic stress disorder (PTSD) is common among war veterans."	1.35	An open-label study of mirtazapine as treatment for combat-related PTSD. ( Alderman, CP; Condon, JT; Gilbert, AL, 2009)

Research

Studies (22)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Adverse Effects

Alternative Measure of PTSD Severity

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (9.09)	18.2507
2000's	8 (36.36)	29.6817
2010's	11 (50.00)	24.3611
2020's	1 (4.55)	2.80

Authors	Studies
Sandahl, H	2
Jennum, P	2
Baandrup, L	2
Lykke Mortensen, E	1
Carlsson, J	3
Poschmann, IS	1
Saguin, E	2
Keou, S	2
Ratnam, C	2
Mennessier, C	2
Delacour, H	2
Lahutte, B	2
Plantamura, J	1
Waltereit, R	1
Eifler, S	1
Schirmbeck, F	1
Zink, M	1
Schneier, FR	1
Campeas, R	1
Carcamo, J	1
Glass, A	1
Lewis-Fernandez, R	1
Neria, Y	1
Sanchez-Lacay, A	1
Vermes, D	1
Wall, MM	1
Buhmann, CB	1
Nordentoft, M	1
Ekstroem, M	1
Mortensen, EL	1
Schuch, LG	1
Yip, A	1
Nouri, KF	1
Gregersen, M	1
Cason, B	1
Kukreja, J	1
Wozniak, C	1
Brzezinski, M	1
Alderman, CP	1
Condon, JT	1
Gilbert, AL	1
Dholakia, R	1
Schleifer, SJ	1
Ahmad, YJ	1
Narang, IS	1
Udo, I	1
Gash, A	1
Counsell, H	1
Johnson, S	1
Reed, RV	1
Fazel, M	1
Goldring, L	1
Lewis, JD	1
Bahk, WM	2
Pae, CU	2
Tsoh, J	1
Chae, JH	2
Jun, TY	2
Kim, KS	1
Davidson, JR	3
Weisler, RH	2
Butterfield, MI	1
Casat, CD	1
Connor, KM	2
Barnett, S	1
van Meter, S	1
Chung, MY	1
Min, KH	1
Jun, YJ	1
Kim, SS	1
Kim, WC	1
Jun, EM	1
Kim, W	1
Vaishnavi, S	1
Connor, K	1
Ahearn, E	1
Falkai, P	1
Good, C	1
Petersen, C	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial[NCT02761161]	Phase 4	241 participants (Actual)	Interventional	2016-03-31	Completed
Combined Mirtazapine and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment of Post-traumatic Stress Disorder (PTSD)[NCT01178671]	Phase 4	38 participants (Actual)	Interventional	2010-07-31	Completed
The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial[NCT00917397]	Phase 4	280 participants (Actual)	Interventional	2009-06-30	Completed
Evaluation of Blended Stepped-care Mental Well-being Intervention for Adults: A Randomized Controlled Trial[NCT05395312]		402 participants (Anticipated)	Interventional	2022-07-30	Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	percentage of subject dropped due to AEs (Number)
Sertraline and Mirtazapine	22.2
Sertraline and Sugar Pill	33.3

as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe) (NCT01178671)
Timeframe: up to 24 weeks

Depression Severity

Intervention	units on a scale (Mean)
Sertraline and Mirtazapine	3.4
Sertraline and Sugar Pill	6.7

as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression). (NCT01178671)
Timeframe: up to 24 weeks

PTSD Self-rated Severity

Intervention	units on a scale (Mean)
Sertraline and Mirtazapine	6.4
Sertraline and Sugar Pill	11.6

as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe). (NCT01178671)
Timeframe: up to 24 weeks

PTSD Severity

Intervention	units on a scale (Mean)
Sertraline and Mirtazapine	33.2
Sertraline and Sugar Pill	39.2

PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe). (NCT01178671)
Timeframe: up to 24 weeks

Remission Status

Intervention	units on a scale (Mean)
Sertraline and Mirtazapine	23.8
Sertraline and Sugar Pill	34.6

Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint (NCT01178671)
Timeframe: up to 24 weeks

Response Status

Intervention	percentage of subjects (Number)
Sertraline and Mirtazapine	39
Sertraline and Sugar Pill	11

Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint (NCT01178671)
Timeframe: up to 24 weeks

Sexual Functioning

Intervention	percentage of subjects (Number)
Sertraline and Mirtazapine	56
Sertraline and Sugar Pill	22

as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired). (NCT01178671)
Timeframe: up to 24 weeks

Sleep Quality

Intervention	units on a scale (Mean)
Sertraline and Mirtazapine	16.3
Sertraline and Sugar Pill	17.4

as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired). (NCT01178671)
Timeframe: up to 24 weeks

Article	Year
[Posttraumatic stress disorder]. Praxis, 2013, Jan-02, Volume: 102, Issue:1 Topics: Adolescent; Adult; Antidepressive Agents; Child; Cognitive Behavioral Therapy; Combined Modality The	2013
Mirtazapine: other indications. The Journal of clinical psychiatry, 1999, Volume: 60 Suppl 17 Topics: Adult; Antidepressive Agents, Tricyclic; Anxiety Disorders; Clinical Trials as Topic; Depressive Dis	1999

Article	Year
Imagery rehearsal therapy and/or mianserin in treatment of refugees diagnosed with PTSD: Results from a randomized controlled trial. Journal of sleep research, 2021, Volume: 30, Issue:4 Topics: Adult; Female; Humans; Imagery, Psychotherapy; Male; Mianserin; Middle Aged; Refugees; Sleep Wake Di	2021
Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial. Trials, 2017, Nov-06, Volume: 18, Issue:1 Topics: Clinical Protocols; Combined Modality Therapy; Denmark; Humans; Imagery, Psychotherapy; Mianserin; R	2017
COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. Depression and anxiety, 2015, Volume: 32, Issue:8 Topics: Adult; Antidepressive Agents, Tricyclic; Double-Blind Method; Drug Therapy, Combination; Female; Hum	2015
The effect of flexible cognitive-behavioural therapy and medical treatment, including antidepressants on post-traumatic stress disorder and depression in traumatised refugees: pragmatic randomised controlled clinical trial. The British journal of psychiatry : the journal of mental science, 2016, Volume: 208, Issue:3 Topics: Adult; Antidepressive Agents; Cognitive Behavioral Therapy; Combined Modality Therapy; Denmark; Depr	2016
Effects of mirtazapine in patients with post-traumatic stress disorder in Korea: a pilot study. Human psychopharmacology, 2002, Volume: 17, Issue:7 Topics: Adult; Antidepressive Agents, Second-Generation; Female; Humans; Korea; Male; Mianserin; Mirtazapine	2002
Mirtazapine vs. placebo in posttraumatic stress disorder: a pilot trial. Biological psychiatry, 2003, Jan-15, Volume: 53, Issue:2 Topics: Adult; Analysis of Variance; Antidepressive Agents, Tricyclic; Double-Blind Method; Female; Humans;	2003
Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial. Human psychopharmacology, 2004, Volume: 19, Issue:7 Topics: Adult; Aged; Humans; Korea; Male; Mianserin; Middle Aged; Mirtazapine; Sertraline; Stress Disorders,	2004
The effectiveness of mirtazapine in the treatment of post-traumatic stress disorder: a 24-week continuation therapy. Psychiatry and clinical neurosciences, 2005, Volume: 59, Issue:6 Topics: Adult; Antidepressive Agents; Female; Humans; Long-Term Care; Male; Mianserin; Mirtazapine; Psychiat	2005
A pilot study of mirtazapine in post-traumatic stress disorder. International clinical psychopharmacology, 1999, Volume: 14, Issue:1 Topics: Adolescent; Adult; Antidepressive Agents, Tricyclic; Female; Humans; Male; Mianserin; Middle Aged; M	1999

Article	Year
Severe rhabdomyolysis induced by quetiapine and mirtazapine in a French military soldier. Journal of the Royal Army Medical Corps, 2018, Volume: 164, Issue:2 Topics: Adult; Antidepressive Agents, Tricyclic; Antipsychotic Agents; France; Humans; Male; Mianserin; Mili	2018
[Antipsychotic induced rhabdomyolysis]. Annales de biologie clinique, 2018, 06-01, Volume: 76, Issue:3 Topics: Adult; Antipsychotic Agents; Humans; Male; Mianserin; Mirtazapine; Rhabdomyolysis; Stress Disorders,	2018
Visual and auditory hallucinations associated with citalopram treatment. Journal of clinical psychopharmacology, 2013, Volume: 33, Issue:4 Topics: Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Citalopram; Depressive D	2013
Serotonin Syndrome Following an Uncomplicated Orthopedic Surgery in a Patient With Post-Traumatic Stress Disorder. Military medicine, 2016, Volume: 181, Issue:9 Topics: Adult; Citalopram; Diskectomy; Drug-Related Side Effects and Adverse Reactions; Humans; Low Back Pai	2016
An open-label study of mirtazapine as treatment for combat-related PTSD. The Annals of pharmacotherapy, 2009, Volume: 43, Issue:7 Topics: Antidepressive Agents, Tricyclic; Australia; Combat Disorders; Dose-Response Relationship, Drug; Hum	2009
Delayed-onset mirtazapine-related leukopenia and rechallenge. Journal of clinical psychopharmacology, 2010, Volume: 30, Issue:6 Topics: Adult; Antidepressive Agents, Tricyclic; Dose-Response Relationship, Drug; Dysthymic Disorder; Femal	2010
Challenges in management of complex panic disorder in a palliative care setting. BMJ case reports, 2012, Oct-09, Volume: 2012 Topics: Anti-Anxiety Agents; Anxiety; Breathing Exercises; Comorbidity; Death; Dibenzothiazepines; Eye Movem	2012
Road traffic accidents: more than just whiplash? BMJ case reports, 2013, Jan-22, Volume: 2013 Topics: Accidents, Traffic; Antidepressive Agents; Drug Therapy, Combination; Female; Humans; Mianserin; Mid	2013
Mirtazapine for PTSD nightmares. The American journal of psychiatry, 2002, Volume: 159, Issue:11 Topics: Antidepressive Agents; Dreams; Humans; Mianserin; Mirtazapine; Refugees; Sleep Initiation and Mainte	2002
An abbreviated version of the Connor-Davidson Resilience Scale (CD-RISC), the CD-RISC2: psychometric properties and applications in psychopharmacological trials. Psychiatry research, 2007, Aug-30, Volume: 152, Issue:2-3 Topics: Antidepressive Agents; Anxiety Disorders; Clinical Trials as Topic; Cyclohexanols; Depressive Disord	2007
SSRI and mirtazapine in PTSD. Journal of the American Academy of Child and Adolescent Psychiatry, 2001, Volume: 40, Issue:3 Topics: Adrenergic alpha-Antagonists; Child; Child Abuse, Sexual; Drug Therapy, Combination; Female; Humans;	2001

mianserin and Stress Disorders, Post-Traumatic