Clinical trials and observational studies of antidepressants in children: ‘what a waste’

Related post: The Lost Children (2015) – @AntiDepAware (Jan 4th, 2016)

Related article: Ioannidis John P A. Clinical trials: what a waste

Query (January 4th, 2016):

Search Terms: antidepressant
Recruitment: Closed Studies (studies with results)
Outcome: Suicide
Age Group: Child

k okltéléchargementhttps://clinicaltrials.gov/ct2/results?term=antidepressant&recr=Closed&rslt=With&outc=suicide&age=0&pg=1

Serious psychiatric adverse events reported by each one of these 10 studies (interventional: 8 / observational: 2) follows.

– 1/10,kp,mkoptéléchargement

  Duloxetine   Placebo   Duloxetine/Duloxetine-Extension Treatment   Placebo/Duloxetine-Extension Treatment   Duloxetine-Taper   Placebo-Taper
Total, serious adverse events
# participants affected / at risk  1/135 (0.74%) 0/137 (0.00%)   2/104 (1.92%)   2/106 (1.89%)  1/97 (1.03%)   1/7 (14.29%)
Psychiatric disorders
Acute psychosis † 1
# participants affected / at risk   0/135 (0.00%)   0/137 (0.00%)   0/104 (0.00%)   1/106 (0.94%)   0/97 (0.00%)   0/7 (0.00%)
# events   0   0   0   1   0   0
Bipolar disorder † 1
# participants affected / at risk   0/135 (0.00%)   0/137 (0.00%)   0/104 (0.00%)   1/106 (0.94%)   0/97 (0.00%)   0/7 (0.00%)
# events   0   0   0   1   0   0
Self-injurious ideation † 1
# participants affected / at risk  1/135 (0.74%)  0/137 (0.00%)   0/104 (0.00%)   0/106 (0.00%)  0/97 (0.00%)   0/7 (0.00%)
# events   1   0   0   0   0   0
Suicidal ideation † 1 [3]
# participants affected / at risk  1/135 (0.74%)  0/137 (0.00%)   1/104 (0.96%) 0/106 (0.00%) 1/97 (1.03%) 1/7 (14.29%)
# events   1   0   1   0   1   1
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 16.0
[3] SAE reported for 1 participant (Duloxetine/Duloxetine group) during the extension treatment period and resolved during the duloxetine-taper period. The SAE was counted in both periods, although it was not new or worsening during the taper period.

2/10

,lp,p,plñtéléchargement

Serious Adverse Events

  Duloxetine – Period II/III   Duloxetine – Period IV
Total, serious adverse events
# participants affected / at risk   5/72 (6.94%)   0/48 (0.00%)
Psychiatric disorders
Depression † 1
# participants affected / at risk   1/72 (1.39%)   0/48 (0.00%)
# events   1   0
Oppositional defiant disorder † 1
# participants affected / at risk   1/72 (1.39%)   0/48 (0.00%)
# events   1   0
Self injurious behaviour † 1
# participants affected / at risk   2/72 (2.78%)   0/48 (0.00%)
# events   2   0
Suicidal ideation † 1
# participants affected / at risk   1/72 (1.39%)   0/48 (0.00%)
# events   1   0

3/10

,p,pñtéléchargement
Psychiatric disorders
Dissociative disorder † 1
# participants affected / at risk   1/2157 (0.05%)
# events   1
Completed suicide † 1
# participants affected / at risk   1/2157 (0.05%)
# events   1
Suicidal ideation † 1
# participants affected / at risk   1/2157 (0.05%)
# events   1

4/10

k j

  DVS SR – Children   DVS SR – Adolescents
Total, serious adverse events
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)
Psychiatric disorders
Negativism (oppositional behavior) * 1
# participants affected / at risk   1/20 (5.00%)   0/20 (0.00%)

5/10

,0imokmotéléchargement

  Sertraline
Total, serious adverse events
# participants affected / at risk   2/517 (0.39%)
Psychiatric disorders
Dissociative disorder † 1
# participants affected / at risk   1/517 (0.19%)
# events   1
Completed suicide † 1
# participants affected / at risk   1/517 (0.19%)
# events   1

6/10

,lkmkomokmt4

  Milnacipran
Total, serious adverse events
# participants affected / at risk   2/57 (3.51%)
Hepatobiliary disorders
Cholecystitis † 1
# participants affected / at risk   1/57 (1.75%)
Psychiatric disorders
Suicidal Ideation † 1
# participants affected / at risk   1/57 (1.75%)

 

7/10

moimio

 

  Duloxetine – Acute   Fluoxetine – Acute   Placebo – Acute   Duloxetine – Extension   Fluoxetine – Extension   Placebo/Duloxetine – Extension
Total, serious adverse events
# participants affected / at risk   3/117 (2.56%)   2/117 (1.71%)   1/103 (0.97%)   1/83 (1.20%)   4/92 (4.35%)   4/86 (4.65%)
Psychiatric disorders
Adjustment disorder with disturbance of conduct † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   1/92 (1.09%)   0/86 (0.00%)
# events   0   0   0   0   1   0
Conversion disorder † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   1/86 (1.16%)
# events   0   0   0   0   0   1
Drug abuse † 1
# participants affected / at risk   1/117 (0.85%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   0/86 (0.00%)
# events   1   0   0   0   0   0
Hypomania † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   1/92 (1.09%)   0/86 (0.00%)
# events   0   0   0   0   1   0
Major depression † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   1/103 (0.97%)   0/83 (0.00%)   0/92 (0.00%)   1/86 (1.16%)
# events   0   0   1   0   0   1
Panic attack † 1
# participants affected / at risk   1/117 (0.85%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   0/86 (0.00%)
# events   1   0   0   0   0   0
Restlessness † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   1/86 (1.16%)
# events   0   0   0   0   0   1
Social phobia † 1
# participants affected / at risk   1/117 (0.85%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   0/86 (0.00%)
# events   1   0   0   0   0   0
Suicidal ideation † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   0/92 (0.00%)   1/86 (1.16%)
# events   0   0   0   0   0   1
Suicide attempt † 1
# participants affected / at risk   0/117 (0.00%)   0/117 (0.00%)   0/103 (0.00%)   0/83 (0.00%)   1/92 (1.09%)   0/86 (0.00%)
# events   0   0   0   0   1   0

8/10

,kom ijjhnhi téléchargement

  Duloxetine 60 mg – Acute   Duloxetine 30 mg – Acute   Fluoxetine 20 mg – Acute   Placebo – Acute   Duloxetine 60 mg – Extension   Duloxetine 30 mg – Extension   Fluoxetine 20 mg – Extension   Placebo/Duloxetine – Extension
Total, serious adverse events
# participants affected / at risk   4/108 (3.70%)   2/116 (1.72%)   6/117 (5.13%)   2/122 (1.64%)   3/73 (4.11%)   2/81 (2.47%)   1/84 (1.19%)   4/82 (4.88%)
Psychiatric disorders
Abnormal behaviour † 1
# participants affected / at risk   0/108 (0.00%)   0/116 (0.00%)   1/117 (0.85%)   0/122 (0.00%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   0   1   0   0   0   0   0
Aggression † 1
# participants affected / at risk   0/108 (0.00%)   0/116 (0.00%)   2/117 (1.71%)   0/122 (0.00%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   0   2   0   0   0   0   0
Depression † 1
# participants affected / at risk   0/108 (0.00%)   0/116 (0.00%)   0/117 (0.00%)   0/122 (0.00%)   0/73 (0.00%)   1/81 (1.23%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   0   0   0   0   1   0   0
Depressive symptom † 1
# participants affected / at risk   0/108 (0.00%)   1/116 (0.86%)   0/117 (0.00%)   0/122 (0.00%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   1   0   0   0   0   0   0
Hallucination † 1
# participants affected / at risk   0/108 (0.00%)   1/116 (0.86%)   0/117 (0.00%)   0/122 (0.00%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   1   0   0   0   0   0   0
Homicidal ideation † 1
# participants affected / at risk   0/108 (0.00%)   0/116 (0.00%)   0/117 (0.00%)   1/122 (0.82%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   0   0   1   0   0   0   0
Self injurious behaviour† 1
# participants affected / at risk   0/108 (0.00%)   1/116 (0.86%)   0/117 (0.00%)   1/122 (0.82%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   0   1   0   1   0   0   0   0
Suicidal ideation † 1
# participants affected / at risk   1/108 (0.93%)   0/116 (0.00%)   2/117 (1.71%)   0/122 (0.00%)   0/73 (0.00%)   0/81 (0.00%)   0/84 (0.00%)   0/82 (0.00%)
# events   1   0   2   0   0   0   0   0
Suicide attempt † 1
# participants affected / at risk   0/108 (0.00%)   0/116 (0.00%)   0/117 (0.00%)   1/122 (0.82%)   1/73 (1.37%)   2/81 (2.47%)   0/84 (0.00%)   1/82 (1.22%)
# events   0   0   0   1   1   2   0   1

9/10

miomoijnijhtéléchargement

 

Total, serious adverse events  Olanzapine/Fluoxetine Combination  Placebo
# participants affected / at risk   9/170 (5.29%)   6/85 (7.06%)
Immune system disorders
Anaphylaxis † 1
# participants affected / at risk   0/170 (0.00%)   1/85 (1.18%)
# events   0   1
Infections and infestations
Pyoderma † 1
# participants affected / at risk   0/170 (0.00%)   1/85 (1.18%)
# events   0   1
Psychiatric disorders
Aggression aggravated † 1
# participants affected / at risk   2/170 (1.18%)   1/85 (1.18%)
# events   3   1
Agitation † 1
# participants affected / at risk   1/170 (0.59%)   0/85 (0.00%)
# events   1   0
Bipolar affective disorder aggravated † 1
# participants affected / at risk   1/170 (0.59%)   0/85 (0.00%)
# events   1   0
Depression worsened † 1
# participants affected / at risk   0/170 (0.00%)   1/85 (1.18%)
# events   0   1
Homicidal ideation † 1
# participants affected / at risk   1/170 (0.59%)   0/85 (0.00%)
# events   1   0
Psychosis aggravated † 1
# participants affected / at risk   0/170 (0.00%)   1/85 (1.18%)
# events   0   1
Self injurious behavior † 1
# participants affected / at risk   1/170 (0.59%)   0/85 (0.00%)
# events   1   0
Suicidal ideation † 1
# participants affected / at risk   2/170 (1.18%)   1/85 (1.18%)
# events   2   1
Suicide attempt † 1
# participants affected / at risk   1/170 (0.59%)   0/85 (0.00%)
# events   2   0

10/10

ko kttéléchargement

 

  Desvenlafaxine 10 mg Children   Desvenlafaxine 25 mg Children   Desvenlafaxine 50 mg Children   Desvenlafaxine 100 mg Children   Desvenlafaxine 25 mg Adolescent   Desvenlafaxine 50 mg Adolescent   Desvenlafaxine 100 mg Adolescent   Desvenlafaxine 200 mg Adolescent
Total, serious adverse events
# participants affected / at risk   0/6 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/7 (0.00%)   1/7 (14.29%)   0/7 (0.00%)   0/8 (0.00%)   0/8 (0.00%)
Psychiatric disorders
Suicidal behaviour † 1
# participants affected / at risk   0/6 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/7 (0.00%)   1/7 (14.29%)   0/7 (0.00%)   0/8 (0.00%)   0/8 (0.00%)

Are these study results reliable? Re: I don’t think so, there are several methodological flaws in each one of these studies, aside from the study design a very big red flag follows.

 

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