Trial Outcomes & Findings for Treating Depression With Transcranial Direct Current Stimulation (tDCS) (NCT NCT00481988)

Results Overview

The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS \< 10 for 2 weeks.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Two weeks

Results posted on

2013-05-20

Participant Flow

Dates of recruitment period: 2006-2009 Location: community Approved sample size: 23 Total number of participants enrolled: 19

One patient was dropped by the investigator when he had a Hamilton Depression Rating Scale (HDRS) of 8 prior to baseline ratings (DRSS 20 is the minimum for inclusion in the study).

Participant milestones

Participant milestones
Measure	Iomed II Phoresor Transcranial Direct Current Stimulation The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.	Sham Iomed II Phoresor Transcranial Direct Current Stimulation The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Overall Study STARTED	12	9
Overall Study Crossover	11	8
Overall Study COMPLETED	11	8
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Iomed II Phoresor Transcranial Direct Current Stimulation The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.	Sham Iomed II Phoresor Transcranial Direct Current Stimulation The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Direct Current Stimulation n=11 Participants one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation	Sham tDCS n=8 Participants the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45 years STANDARD_DEVIATION 2 • n=5 Participants	45 years STANDARD_DEVIATION 2 • n=7 Participants	45 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

Population: 20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.

The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS \< 10 for 2 weeks.

Outcome measures

Outcome measures
Measure	Transcranial Direct Current Stimulation n=9 Participants one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation	Sham tDCS n=8 Participants the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).	2 participants	2 participants

SECONDARY outcome

Timeframe: Two weeks

Population: Data for the secondary outcome measure was incompletely collected and not analyzed.

patient self report of depressive symptoms

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Direct Current Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcranial Direct Current Stimulation n=19 participants at risk one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation	Sham tDCS n=8 participants at risk the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
Injury, poisoning and procedural complications scalp burn	10.5% 2/19 • Number of events 2 • 2 months	0.00% 0/8 • 2 months

Additional Information

Peter Bulow MD, Assistant Professor of Clinical Psychiatry

Division of Experimental Therapeutics, NY State Psychiatric Organization

Phone: (212) 543 5664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place