Clinical Trial: Magnetic Stimulation of the Brain in Schizophrenia or Depression

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Magnetic Stimulation of the Brain in Schizophrenia or Depression: A Randomized, Double Blind, Sham Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Schizophrenia or Depression

Brief Summary: The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS) with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression. Other objectives are to increase the understanding of the underlying neurobiology of negative symptoms and the mechanisms for the treatment effect of rTMS.

Detailed Summary:

This is a double blind parallel randomized sham controlled trial. The intervention is intermittent theta-burst stimulation (iTBS), which is rTMS with theta burst frequency with 2400 pulses/day in two sessions at 90% of resting motor threshold intensity over the DMPFC, given in ten days on week days (10 treatment days must be completed within a maximum of 21 days). Stratified (depression and schizophrenia diagnosis) block randomization will be used for treatment allocation to active or sham side of the stimulation coil.

Patients will be referred from their regular psychiatric care facilities. At the screening visit the patient will be assessed if fulfilling all inclusion and none of the exclusion criteria. At the baseline visit thorough psychiatric, cognitive and neurophysiological examination will be performed. The latter include investigation of cortical excitability with paired-pulse TMS, mismatch negativity (MMN, a measure of aberrant stimulus detection), startle-response, habituation, electrodermal activity (EDA), near-infrared spectroscopy (NIRS), 24 hour actigraphy and heart rate registration.

During 10 week days the participants will receive a daily rTMS (or sham) treatment. On the day after last rTMS treatment the examinations performed at the baseline visit will be repeated. Four weeks after baseline there is a shorter visit to follow-up symptoms and functioning. At the end of this visit the blinding is unmasked and patients who have received sham rTMS will be offered active treatment in an open-phase. After the four weeks follow-up there are two additional and identical visits at 10 and 26 weeks after start of treatment.


Sponsor: Uppsala University

Current Primary Outcome: Mean change of total score on the Clinical Assessment Interview for Negative Symptoms (CAINS). [ Time Frame: From baseline to day after last treatment, i.e. 14-21 days after baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean change of total score on the CAINS [ Time Frame: From baseline to four weeks after baseline. ]
  • Change in Clinical Global Impression (CGI) score [ Time Frame: From baseline to four weeks after baseline. ]


Original Secondary Outcome: Same as current

Information By: Uppsala University

Dates:
Date Received: September 14, 2016
Date Started: October 2016
Date Completion: December 2019
Last Updated: October 12, 2016
Last Verified: October 2016