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Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
other: In vitro drug study and Clinical Study
Adequacy of study:
supporting study
Study period:
1981
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Data not sufficient for evaluation.

Data source

Reference
Reference Type:
publication
Title:
Effects of Psychotropic Drugs on Human Sperm Motility
Author:
Levin et al.
Year:
1981
Bibliographic source:
Fertil.Steril. 55:503-506

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
toxicity to reproduction / fertility

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Method

Type of population:
other: male patients suffering from clinical depression
Ethical approval:
not specified

Results and discussion

Applicant's summary and conclusion

Conclusions:
The study demonstrated reduced sperm viability in men under lithium therapy (serum levels: 22-52 mg/L, equivalent to 3.2-7.5 mmol/L). However, the number of cases is low (n=4) and the significance of these isolated findings is limited.
Executive summary:

The effects of acute treatment of depressed patients with lithium carbonate on sperm function were investigated. In addition, it was studied the direct in vitro effects of a variety of neurotropic agents on sperm motility. There were no significant differences in sperm count, viability, or motility between a group of patients diagnosed as having clinical depression and a group of semen donors with normal sperm characteristics. Three weeks of continuous therapy with lithium carbonate resulted in a significant decrease in sperm viability but no significant change in sperm count or motility. The in vitro drug studies demonstrated that lithium carbonate had no effect on motility.

The effect noted does not allow any conclusion as the number of cases is very low and confounding factors were not considered.