The Effect Of Fluvoxamine On Sleep Architecture Of Depressed Patients With Insomnia: An 8-Week, Open-Label, Baseline-Controlled Study

Figures & data

Figure 1 Flowchart representing the selection of depressive patients with insomnia.

Abbreviations: PSG, polysomnogram; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; HRSD, Hamilton Rating Scale for Depression; OSA, Obstructive Sleep Apnoea; PLMS, Periodic Limb Movement during Sleep.

Table 1 Demographic And Clinical Characteristics Of Depressed Patients (n=31)

	Mean ± Standard Derivation, (Range) Or Number
Demographic characteristics
Age (in years)	34.1±8.9 (20–55)
Gender (male/female)	13/18
Marriage (married/single/divorced or widowed)	18/7/6
Occupation (full-time/part-time/no job or retired)	14/8/9
Education (university or above/middle school/primary school or below)	10/14/7
Resident (urban/town/rural)	13/12/6
Clinical characteristics
Age onset (in years)	25.2±9.1 (17–38)
Total duration of illness (years)	8.4±7.7 (0–24)
Single type/recurrent type	10/21
Number of illness episodes	2.8±1.7 (1–5)
Length of current illness (in weeks)	5.9±4.7 (1–14)

Table 2 Clinical And Polysomnographic Parameters Across The Fluvoxamine Treatment In Depressed Patients

	Baseline (n=31)	14th Day (n=26)	28th Day (n=25)	56th Day (n=23)	Statistics	Pairwise Comparison (p<0.05)
Dosage (mg/day)		133.7±38.9	144.3±61.4	157.0±63.1	F=2.71
HRSD	25.3±6.8	13.9±5.6	10.3±3.5	7.0±2.3	F=12.54***	a, b, c, e
Remitted^#/nonremitted (n)	0/31	6/20	10/15	11/12	χ^2=19.38***	a, b, c
HRSD-sleep disturbance factor	4.3±3.1	3.6±2.8	2.6±1.5	2.4±1.3	F=6.01*	b, c
Non-insomnia^##/Insomnia (n)	0/31	11/15	15/10	14/9	χ^2=29.42***	a, b, c
TESS-S		0.8±0.6	0.7±0.8	0.7±0.5	KW=0.69
TESS-T		0.9±0.8	0.6±0.7	0.8±0.6	KW=0.73
PSQI	15.3±7.4	9.8±4.4	6.5±3.1	6.6±3.8	F=10.77***	a, b, c
ESS	7.8±4.8	5.2±3.7	3.5±3.0	4.1±3.5	F=9.66**	a, b, c
TRT (min)	499.8±80.3	487.3±81.4	502.1±63.6	496.3±67.8	F=1.008
TST (min)	339.5±111.4	422.1±69.5	435.6±83.3	429.0±78.4	F=5.11**	a, b, c
SE (%)	67.9±25.3	86.6±29.9	86.7±27.3	86.5±31.1	F=4.88*	a, b, c
SL (min)	60.3±33.2	27.6±17.0	22.3±12.1	23.4±13.8	F=9.38***	a, b, c
REM Latency (min)	73.6±37.0	118.9±69.1	107.7±70.9	109.1±71.6	F=7.05***	a, b, c
WASO (min)	99.9±43.1	37.6±16.4	44.2±21.8	43.9±19.3	F=5.93**	a, b, c
Arousal Index	11.3±6.9	7.8±5.9	5.9±3.8	6.1±4.5	F=3.664*	b, c
% S1	17.4±4.3	13.3±5.0	6.7±2.6	7.5±4.2	F=5.098**	b, c
% S2	56.8±21.0	58.2±18.6	57.4±17.9	58.0±20.9	F=1.795
% S3	4.6±1.4	12.6±5.4	16.7±8.0	17.6±7.7	F=11.630***	a, b, c, d, e
% REM sleep	21.4±8.0	15.9±7.7	17.2±10.3	16.8±8.4	F=3.991*	a

Notes: ^#Remitted: HRSD≤7. ^##Insomnia: sleep disturbance factor in HSRD≥4. F: analysis of variance; KW: Kruskal-Wallis test. *: P<0.05; **: P<0.01; ***: P<0.001. Pairwise comparison: a, baseline versus 14th day; b, baseline versus 28^th day; c, baseline versus 56th day; d, 14th day versus 28th day; e, 14th day versus 56^th day; f, 28^th day versus 56th day.

Abbreviations: HRSD, Hamilton rating scale for depression; TESS-S, treatment-emergent symptom scale-severity; TESS-T, treatment-emergent symptom scale-treatment; PSQI, Pittsburgh sleep quality index; ESS, Epworth sleepiness scale; TRT, total recording time; TST, total sleep time; SE, sleep efficiency; SL, sleep latency; WASO, wake after sleep onset; S1, Stage 1 sleep; S2, Stage 2 sleep; S3, Stage 3 sleep; REM, rapid eye movement.

Table 3 Comparison Of Clinical And Polysomnographic Parameters Between The Insomnia Group (n=9) And The Non–Insomnia Group (n=14) At The End Point Of This Trial (the 56th Day)

	Insomnia* (n=9)	Non-Insomnia* (n=14)	Statistics
Clinical parameters
Dosage (mg/d)	193.5±70.8	127.1±44.2	T=6.39; P=0.003
HRSD	10.2±3.4	5.3±1.8	T=10.84; P=0.000
Remitted^#/nonremitted (n)	1/8	10/4	χ^2=8.811; P=0.004
TESS-S	0.7±0.8	0.6±0.6	Z= 0.39; P=0.654
TESS-T	1.0±0.8	0.8±0.9	Z= 0.27; P=0.703
PSQI	8.2±5.5	5.1±3.1	T=4.45; P=0.019
ESS	4.3±3.6	3.8±2.2	Z=1.78; P=0.437
Polysomnographic parameters
Sleep continuity
TRT (min)	503.7±89.4	488.4±65.1	T=0.97; P=0.487
TST (min)	417.1±77.7	436.1±70.8	T=0.61; P=0.325
SE (%)	82.8±37.2	89.3±35.6	T=1.32; P=0.109
SL (min)	28.6±14.2	19.8±8.3	T=4.03; P=0.036
REM sleep latency (min)	114.5±58.3	107.1±49.6	T=0.76; P=0.505
WASO (min)	57.8±31.7	32.5±19.3	T=8.30; P=0.016
Arousal Index	10.1±6.9	4.7±2.5	T=6.88; P=0.030
Sleep architecture
% S1	11.2±6.0	4.7±2.5	T=7.14; P=0.007
% S2	59.5±20.9	56.8±20.9	T=0.29; P=0.675
% S3	12.9±8.4	19.7±10.5	T=4.30; P=0.029
% REM sleep	16.3±7.5	18.8±11.3	T=1.83; P=0.468

Notes: *Insomnia: sleep disturbance factor score in HRSD≥4. ^#Remitted: HRSD≤7. T: t test; Z: Mann–Whitney U-test.

Abbreviations: HRSD, hamilton rating scale for depression; TESS-S, treatment-emergent symptom scale-severity; TESS-T, treatment-emergent symptom scale-treatment; PSQI, Pittsburgh sleep quality index; ESS, epworth sleepiness scale; TRT, total recording time; TST, total sleep time; SE, sleep efficiency; SL, sleep latency; WASO, wake after sleep onset; S1, Stage 1 sleep; S2, Stage 2 sleep; S3, Stage 3 sleep; REM, rapid eye movement.

Availability Of Data And Materials

The data and materials for the current study are available from the corresponding author on reasonable request.