Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCharite University, Berlin, Germany
About this trial
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Declaration of consent
Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients
Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P-PANSS)
German should either be the native language or spoken at a native level
Disqualifiers
Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS)
Acute suicidality
Acute consumption phase of a substance dependence, except nicotine
No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage
Trial design
Design model
Parallel
Treatments tested in this trial
Oxytocin
Other interventionOxytocin nasal spray in combination with mindfulness based group therapy (MBGT).
Placebo
Other interventionPlacebo nasal spray in combination with mindfulness based group therapy (MBGT).
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Oxytocin (24 I.U. Syntocinon®)Active comparator 1 intervention
Group B: Oxytocin (48 I.U. Syntocinon®)Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in BNSS Brief Negative Symptom Scale
The Brief Negative Symptom Scale (BNSS) is a 13-item rater-based instrument designed for clinical trials and other studies that measures 5 domains: blunted affect, alogia, asociality, anhedonia, and avolition. The interrater, test-retest, and internal consistency of the instrument were strong, with respective intraclass correlation coefficients of 0.93 for the BNSS total score and values of 0.89-0.95 for individual subscales. The minimal score is 0 and the maximal score is 78. Higher scores indicate a worse outcome.
Time frame
Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)Secondary outcomes
1
Change and group differences in PANSS Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale (PANSS) is one of the most widely used rater instruments for the assessment of the presence and severity of psychotic symptoms. Each scale comprises seven statements which are rated by the interviewer using a seven-point Likert format (from 1= absent to 7= extreme). The minimal score is 30 and the maximal score is 210. Higher scores indicate a worse outcome. The PANSS is reported to have satisfactory internal consistency, good interrater reliability and construct validity.
Time frame
Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)2
Change and group differences in SNS Self-Evaluation of Negative Symptoms
The Self-Evaluation of Negative Symptoms (SNS) is a 20-item self-reported questionnaire with five subscales, namely alogia, avolition, anhedonia, social withdrawal and diminished emotional range. These subscales cluster on two factors, the apathy and emotional components. Participants can estimate the answer to each question on a scale from 0 (strongly disagree) to 2 (strongly agree). The minimal score is 0 and the maximal score is 40. Higher scores indicate a worse outcome. The scale was shown to have good internal consistency with Cronbach's alpha = .87.
Time frame
Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)3
Change and group differences in CDSS Calgary Depression Scale of Schizophrenia
The Calgary Depression Scale for Schizophrenia (CDSS) is a nine item clinician rated outcome measure that assesses the level of depression in people with schizophrenia. It is the only depression scale designed to assess depression in people with a schizophrenia spectrum disorder. It distinguishes depressive symptoms from negative symptoms and is sensitive to change. The minimal score is 0 and the maximal score is 27. Higher scores indicate a worse outcome.
Time frame
Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)4
Change and group differences in PSS Perceived Stress Scale
The Perceived Stress Scale (PSS) is a well-established, reliable, and valid 10-item self-report scale that measures perceived stress on a 5-point response scale (0 = "never", 1 = "almost never", 2 = "sometimes", 3 = "fairly often", 4 = "very often"). The German version of the PSS has demonstrated good internal consistency (Cronbach's α = 0.84). The minimal score is 10 and the maximal score is 50. Higher scores indicate a worse outcome.
Time frame
Baseline rating (T0), post-intervention rating at week 4 (T8), follow-up 1 (week 8, T9) and follow-up 2 (week 16, T10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov