Schneider-Helmert, Gnirss, Monnier, Schenker, Schoenenberger, 1981 PMID 6895513 |
6 healthy volunteers (4 M / 2 F); double-blind crossover |
Slow IV synthetic DSIP 25 nmol/kg in the morning (historical study condition) |
First human application on the opened record. Subjects reported sleep pressure; total sleep time +59% (median) in a 130-min post-treatment interval vs placebo. Delayed night-sleep: shorter sleep onset, less stage 1, better efficiency. Authors say EEG/behavior did not show classic pharmacologic sedation. n = 6. Not a disease trial. |
A disease indication. An NCT. Independent replication. Equivalence to an SRP research vial. A receptor. |
Schneider-Helmert & Schoenenberger, 1981 PMID 7028502. DOI 10.1007/bf01971753 |
6 middle-aged chronic insomniacs |
Acute IV synthetic DSIP 25 nmol/kg (historical study condition) |
Longer sleep, fewer interruptions, slightly more REM; no daytime sedation. Sleep-promoting effect only in the second hour; first hour “slight arousing effect.” Lasted up to 6 h of night sleep. n = 6. |
Modern RCT design. Independent site. Comparison to an approved hypnotic on a current label. Vial-to-brain PK for research-market material. |
Schneider-Helmert & Schoenenberger, 1983 PMID 6689058. DOI 10.1159/000117964 |
Summary of five human studies; single and repeated IV DSIP; double-blind; psychophysiologic tests + polygraphy |
IV DSIP (slow injection “proved essential”) |
Authors report ~1 h latency of sleep induction, duration up to 20 h; “complete normalization” of disturbed sleep after four consecutive injections in insomniacs; higher daytime alertness/performance. Compatibility described as good. Pooled narrative from the same group; not a large RCT. |
A registered trial. Independent confirmation. Proof that “complete normalization” is a modern efficacy endpoint. |
Schneider-Helmert, 1986 PMID 3792404. DOI 10.1159/000116050 |
18 chronic psychophysiological insomniacs; middle-aged (29–59) vs older (60–83) |
One week DSIP 6 × 30 nmol/kg IV; follow-up week (historical study condition) |
Middle-aged: sleep to “normal values” by end of administration, maintained at follow-up. Elderly: larger immediate effect but “full normalization” only at end of follow-up. Authors correlate effect with severity of disturbance. Sleep-lab study; no NCT; same investigator. |
An NCT. Multi-center independent replication. FDA-label comparison. Research-vial identity. |
Schneider-Helmert, 1987 PMID 3622582. DOI 10.1159/000116143 |
14 middle-aged chronic insomniacs; placebo-controlled, double-blind, 7 nights |
Intermediate-term IV DSIP; polysomnograms at baseline, start, end, and one post-treatment placebo night |
Authors report improved night sleep with first and repeated doses, maintained on first post-treatment placebo night; daytime alertness/performance increased. Efficiency said to reach “levels of normal controls.” n = 14. Not independently replicated on an opened modern trial. |
Modern independent RCT. ClinicalTrials.gov registration. Proof of a receptor. |
Schneider-Helmert, 1986 PMID 3758119. DOI 10.1159/000116097 |
Short summary of double-blind insomniac studies plus a narcolepsy single case |
DSIP injections |
Thin abstract: effects on night sleep and waking; single-case narcolepsy. Does not add independent n. |
Independent n. A narcolepsy program. An NCT. |
Schneider-Helmert, Hermann, Schoenenberger, 1987 PMID 3582201. DOI 10.1055/s-2008-1068167 |
One 47-year-old woman; delayed-sleep-phase insomnia + low-dose benzodiazepine dependence; inpatient, polygraphic |
Intensive-care DSIP for one week |
Authors report advancing main sleep phase by 5 hours, abrupt flunitrazepam withdrawal, “normal” sleep profile; actographic control in an after-treatment week said the change was maintained. n = 1. Not a withdrawal-drug approval study. |
A withdrawal-drug approval. n > 1. An NCT. Equivalence to research-market material. |
Larbig, Gerber, Kluck, Schoenenberger, 1984 PMID 6548970. DOI 10.1159/000115716 |
7 patients (migraine / vasomotor headache, chronic tinnitus, psychogenic pain) |
IV DSIP on 5 consecutive days then 5 injections every 48–72 h (historical study condition) |
Authors: pain lowered in 6 of 7; simultaneous reduction of “depressive states.” Pilot. n = 7. Not a pain-drug trial. |
A pain-drug trial. Sleep-architecture primary endpoint. Independent modern replication. |