SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02658682

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure

Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165). The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.

NCT02658682 Major Depression
MeSH: Depression Depressive Disorder Depressive Disorder, Major
HPO: Depressivity

2 Interventions

Name: Attention Bias Modification

Description: Computer based Attention Bias Modification

Type: Behavioral

ABM +

Name: Sham Attention Bias Modification

Description: Computer based Sham Attention Bias Modification

Type: Behavioral

ABM -


Primary Outcomes

Description: Beck Depression Inventory

Measure: Change in residual symptoms of depression. Self report.

Time: At baseline and immediately after ABM intervention (during first week after ABM).

Description: Hamilton Depression Rating Scale

Measure: Change in residual symptoms of depression. Clinician rating

Time: At baseline and immediately after ABM intervention (during first week after ABM).

Secondary Outcomes

Description: Measured by the MINI structured interview

Measure: Recurrence of major depressive episodes

Time: Will be measured 12 month after baseline

Description: Emotion Regulation Questionnaire (ERQ).

Measure: Changes in Emotion Regulation

Time: At baseline.

Description: The Rumination Response Scale

Measure: Changes in Rumination

Time: At baseline and 12 months after intervention

Description: Cortisol samples from saliva measured by diural variation (6 samples).

Measure: Changes in cortisol response.

Time: At baseline, immediately after ABM intervention and one month after intervention.

Description: Beck Anxiety Inventory

Measure: Changes in symptoms of anxiety

Time: At baseline, immediately after ABM intervention (during first week after ABM intervention), 1 month after intervention, 6 months after intervention and 12 months after intervention

Other Outcomes

Description: Automatic Thought Questionnaire (ATQ)

Measure: Automatic thoughts

Time: At baseline, immediately after ABM intervention (average one day), 1 month after intervention, 6 months after intervention and 12 months after intervention

Description: Perceived Stress Scale (PSS).

Measure: Changes in perceived stress

Time: At baseline, immediately after ABM intervention (average one day), , 1 month after intervention, 6 months after intervention and 12 months after intervention

Description: Positive and Negative Beliefs about Rumination scale (PBRS and NBRS)

Measure: Meta cognitions

Time: At baseline and 12 months after intervention

Measure: 5-HTTLPR+A>G polymorphic variation divided by the triallelic functional "high expressive" versus "low expressive" genotype will moderat the effect of ABM on residual symptoms compared to neutral ABM placebo condition

Time: Immediately after ABM intervention.

Measure: Brain Derived Neurotrophic Factor (BDNF) val66met polymorphic variation linked to Brian Derived Neurotrophic Factor (BDNF) variation will moderate the effect of ABM on residual symptoms compared to neutral ABM placebo condition

Time: Immediately after ABM intervention.

Measure: A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on residual symptoms compared to neutral placebo condition

Time: Immediately after ABM intervention.

Description: Beck Depression Inventory

Measure: Change in residual symptoms of depression. Self report

Time: One month after intervention, 6 months after intervention and 12 months after intervention

Description: Hamilton Depression Rating Scale

Measure: Change in residual symptoms of depression. Clinical rating

Time: One month after intervention, 6 month after intervention and 12 month after intervention

Measure: Primary outcome measures will be modified by the degree of attentional change during the ABM intervention.

Time: Immediately after the ABM intervention

Measure: Primary outcome measures will be modified by executive functioning

Time: At baseline

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

Brain Derived Neurotrophic Factor (BDNF) val66met polymorphic variation linked to Brian Derived Neurotrophic Factor (BDNF) variation will moderate the effect of ABM on residual symptoms compared to neutral ABM placebo condition. --- val66met ---



HPO Nodes


HPO:
Depressivity
Genes 240
VAPB NHLRC1 GABRB3 GABRG2 CTSF ERBB4 CHCHD10 SPAST ATP7B PSAP PSEN1 ATRX PDGFB MYO7A PDGFRB MAPT AMACR RPS6KA3 MATR3 TBC1D7 CYP27A1 LRRK2 GBA CDH23 HMBS DAO PTPN22 RPS20 PDZD7 GCH1 ADGRV1 GPR101 RREB1 PFN1 COQ2 BCR DCTN1 BCS1L ATXN8 HNRNPA1 MECP2 FGF17 TTC19 HIRA NEFH PPARGC1A NEK1 BMPR1A ANOS1 AP2S1 PANK2 KISS1R GLA PER3 CLCN4 PER2 ALMS1 AARS2 CEP78 PROKR2 ATXN2 FIG4 PIK3CA ATXN8OS GLE1 PTS SQSTM1 USH1G KCNJ2 HS6ST1 DGUOK C19ORF12 UFD1 AFG3L2 PCDH15 MLH1 CLN6 FGF8 PLA2G6 SGCE GNA11 CACNA1H CACNA1G TAC3 FGF14 FGFR1 ATXN10 TACR3 GNAS SEMA4A DNA2 KISS1 USH2A CLRN1 GNRH1 KCNT1 GNRHR CFAP410 TBX1 NOTCH3 VCP DNMT1 PDE11A GP1BB TBP PMS1 PROK2 WHRN KRAS TCF4 PMS2 DRD2 DNAJC13 EPM2A CIB2 FMO3 UBQLN2 ANG FMR1 COMT SLC25A4 CLIP2 CISD2 WFS1 GPR35 FA2H RRM2B POLG ANXA11 DUSP6 NR4A2 PON1 TOR1A PON2 PON3 BAZ1B CP TWNK CASR GRN XK MSH2 CHD7 OCRL AIP CPOX RFC2 GTF2IRD1 IDUA USH1C ATP13A2 CBS JMJD1C SLC2A1 MSTO1 ARSG CRKL KCTD17 CHMP2B PPOX FAN1 CCNF MST1 TMEM106B TGFBR2 TARDBP MSH6 USP8 LIMK1 PPP2R2B OPTN MLH3 GTF2I ARSA SNCAIP NSMF CSF1R SEC24C COX1 LMNB1 COX2 COX3 PPT1 ARVCF WDR11 SLC18A2 TK2 SLC20A2 JRK TBK1 ND1 ARMC5 VPS35 SPRY4 ND4 ND5 EIF4G1 ND6 PAH PRKACA TREM2 EHMT1 PRKAR1A GIGYF2 DNAJC5 TRNF PRKCG TRNH TAF15 ELN TRNL1 TRNL2 FUS TRNN MAPK1 COASY HARS TRNQ ATP1A3 TRNS1 SNCA TRNS2 C9ORF72 POLG2 TRNW STX16 HBB EPCAM TNXB TBL2 UNC13A PRNP SOD1 HTT GABRA1 PINK1 JPH3 EPHA4 XPR1 PRPH