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Report for Clinical Trial NCT02690324

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders

development of skin adhesive patches for the monitoring and prediction of mental disorders

NCT02690324 Major Depressive Disorder, Anxiety Disorder
MeSH:Depressive Disorder Depressive Disorder, Major Anxiety Disorders
HPO:Depressivity

1 Interventions

Name: cognitive stress (serial 7)

Type: Behavioral
Group Labels: 3

Major depressive disorder normal control panic disorder


Primary Outcomes

Description: changes of skin conductane level(SCL) and skin conductance response(SCR)

Measure: Electrodermal activity(EDA)

Time: baseline, 0.5, 1,2,3 months

Description: changes of SDNN, RMSSD and LF/HF ratio

Measure: Heart rate variability

Time: baseline, 0.5, 1,2,3 months

Secondary Outcomes

Measure: Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met

Time: baseline, 0.5, 1,2,3 months

Description: IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α

Measure: Cytokines

Time: baseline, 0.5, 1,2,3 months

Measure: Leptin

Time: baseline, 0.5, 1,2,3 months

Measure: Adiponectin

Time: baseline, 0.5, 1,2,3 months

Measure: Epinephrine

Time: baseline, 0.5, 1,2,3 months

Measure: Norepinephrine

Time: baseline, 0.5, 1,2,3 months

Measure: C reactive protein

Time: baseline, 0.5, 1,2,3 months

Description: serum, plasma, platelet BDNF

Measure: BDNF

Time: baseline, 0.5, 1,2,3 months

Description: structured interview assessing for DSM-IV Axis I disorders with strong reliability and validity in relation to the Structured Clinical Interview for DSM-IV (SCID-IV)

Measure: MINI plus

Time: Baseline

Description: assess current and past Axis I diagnoses

Measure: MINI Suicidality Module

Time: baseline, 0.5, 1,2,3 months

Description: changes of HAMD-17 total socres

Measure: Hamilton Depression Rating Scale-17(HAMD-17)

Time: baseline, 0.5, 1,2,3 months

Description: changes of HAMA total scores

Measure: Hamilton Anxiety Rating Scale(HAMA)

Time: baseline, 0.5, 1,2,3 months

Description: ASI-3 to measure the three most supported AS domains: social (i.e., fear of exhibiting symptoms in public that may elicit embarrassment), cognitive (i.e., fear of losing cognitive control or experiencing concentration difficulties), and physical (i.e., fear that physical sensations are a sign of an immediate physical problem).

Measure: Anxiety Sensitivity Index(ASI)

Time: baseline, 0.5, 1,2,3 months

Description: The APPQ (Rapee et al., 1995) is a 27-item instrument that is designed to measure interoceptive, agoraphobic, and social situational fear. Subjects respond to each item on a 9-point Likert scale from 0 to 8, according to how much fear they think they would experience in a given situation so that total scores range from 0 to 216.

Measure: APPQ(Albany Panic and Phobia Questionnaire)

Time: baseline, 0.5, 1,2,3 months

Description: 16-item questionnaire that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me)

Measure: PSWQ(Penn state worry questionnaire)

Time: baseline, 0.5, 1,2,3 months

Description: emotional, somatic, cognitive, and behavioral stress responses.

Measure: SRI(Stress response Inventory)

Time: baseline, 0.5, 1,2,3 months

Description: The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.

Measure: Perceived Stress Scale(PSS)

Time: baseline, 0.5, 1,2,3 months

Description: The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).The BIS-11 is a 30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors.

Measure: Barratt Impulsivity Scale

Time: baseline, 0.5, 1,2,3 months

Description: The items assess panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.

Measure: Panic disorder severity scale(PDSS)

Time: baseline, 0.5, 1,2,3 months

Purpose: Diagnostic

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met. --- Val66Met ---



HPO Nodes


HPO:
HP:0000716: Depressivity
Genes 381
TRNF ARSG FUS ANG PDE11A GLE1 SARS1 PLA2G6 NEK1 SLC18A2 HLA-DRB1 FMN2 TRNS2 XK SMPD1 HTT CHD7 ATXN10 SNCAIP TCF4 ATP1A3 GPR101 DRD2 PDGFB OPTN TWNK RRM2B GBA KCNT1 BCR JPH3 NOTCH3 PDCD1 PAH PIGC HTR2A PRKN DNMT1 TRNL1 ZC3H14 ST3GAL3 USH1G LMNB1 LIMK1 SNCA ADH1C ATRX OCRL PRKACA TBL2 FMR1 PRNP CPOX USP8 PPARGC1A UCHL1 VPS13C GLUD2 KCNJ2 TBK1 MST1 TWNK MSTO1 MAPT B3GALNT2 PPP2R2B PROKR2 PRNP XPR1 RPS20 POLG SQSTM1 ARMC5 NDST1 TRNN TARDBP USH2A TRNL2 GNAS DCPS STX16 TTC19 ATXN10 SLC20A2 TBX1 CSF1R GSN ND1 ATP7B CDH23 TAC3 MYO7A WFS1 TWNK PDGFRB HS6ST1 PRKCG ESPN COX2 HIRA GNAS CLCN4 CASR ARSA GABRA1 GCH1 DNA2 MAPT UBQLN2 GDAP2 FGF8 TOR1A SEMA4A TK2 UFD1 FUS DGUOK EPM2A HARS1 C9ORF72 POLG UNC13A PODXL TBK1 LRRK2 CLIP2 HTRA2 DCTN1 TRAPPC9 C19ORF12 PLA2G6 MATR3 C12ORF4 GRIK2 SLC6A4 PRNP MECP2 CP HLA-DQB1 CFAP410 CACNA1G MED23 AARS2 VCP TRNQ PRNP JMJD1C SRPX2 VAPB MYO7A SGCE CC2D1A VPS35 ABCA7 CCNF EHMT1 C9ORF72 SNCA MLH1 PANK2 DUSP6 CEP78 GABRB3 FIG4 NR4A2 BMPR1A PTPN22 PARK7 MECP2 DNMT1 WASHC4 TRNS1 CACNA1G AMACR VCP ALMS1 IDUA CHMP2B PMS1 GIGYF2 KISS1R TSC1 RPS6KA3 COQ2 ERBB4 KDM5B POLG2 SEC24C SLC2A1 COQ2 DNAJC13 MSTO1 MSH6 FBXO31 RRM2B CHMP2B HTT POLG EDC3 PGAP1 NSMF SLC25A4 ATXN2 PIK3CA THOC2 PER2 GLA CACNA1H TBC1D7 PAH SQSTM1 POLG GNAS PRNP AIMP1 ARMC5 CIB2 LINS1 GABRG2 FGFR1 C9ORF72 CDH23 METTL23 TACR3 EPCAM TRNS1 PPOX KRAS ANOS1 SLC45A1 WARS2 POLG FA2H COASY HLA-DQB1 GNAS TRNL1 PRSS12 CLN6 GBA PMS2 C9ORF72 CLCN4 HBB TSC2 PDGFB AIP PRKAR1A COMT MAPT DNAJC5 CRADD ATXN8 ATXN2 ATP13A2 ARVCF GTF2I WHRN GBA TRNW COX3 KISS1 TREM2 TGFBR2 PDZD7 AFG3L2 PDGFRB BCS1L MAN1B1 SNCA VCP NEFH TRNH COX1 ATP1A3 DAO CPOX PINK1 LRRK2 HMBS CRBN DCTN1 CTSF GPR35 CLIP1 TBX1 ND5 TAF15 ND4 PTS PON3 MED25 DNAJC6 TRNS2 NSUN2 FMO3 SPAST HMBS FGF17 ELN PON1 CBS CYP27A1 FGF14 PSAP FMR1 TMEM106B KCTD17 RREB1 CHCHD10 TWNK TBP AP2S1 ATXN8OS FRRS1L ATXN8OS BAZ1B HNMT FAN1 ADGRV1 PINK1 HNRNPA1 PRPH TUSC3 MBOAT7 PRNP PANK2 FGF14 GABRG2 KCTD17 PDGFRB TECR LMAN2L EIF4G1 GNAS CLRN1 EPHA4 GP1BB JRK IQSEC1 TREM2 MSH2 PSEN1 RFC2 PON2 MAPK1 SGCE PER3 PROK2 GRIN2A TNIK PFN1 MLH3 GRN ND6 CRKL ANXA11 C9ORF72 GNRHR EZR VCP USH1C GNRH1 TOR1A WFS1 POLG NHLRC1 CISD2 CHCHD10 WDR11 SPRY4 PPT1 PCDH15 TBP GTF2IRD1 SOD1 RSRC1 GLT8D1 DCTN1 GNA11 TARDBP