Effects of glutamate modulation on anxiety symptoms

Phase 1

Completed

• Conditions: Anxiety Disorders; Mental Health - Anxiety

• Registration Number: ACTRN12615000617561
• Lead Sponsor: niversity of Otago

Brief Summary

ow dose ketamine has dose-related anti-anxiety effects in patients with treatment refractory GAD/SAD. These effects can be maintained during 3 months of maintenance treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-15
• Study Completion: 2017-12-15
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

GAD patients must have a Hamilton Anxiety Scale (HAM-A) score >20
SP patients must have a Liebowitz Social Anxiety Scale (LSAS) self-report score >50.

Exclusion Criteria

1.Female patients who are or intend to become pregnant, or are lactating
2.Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
3.Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
4.Current use of MAOIs, thyroxine or stimulants (amphetamine/methyphenidate). Use of antidepressants or other anxiolytics at stable doses > 4 weeks is acceptable.
5.Patients with severe acute or chronic medical illnesses.
6.Patients with current active suicidal ideation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in anxiety rating scales (GAD: Hamilton Anxiety Scale (HAM-A); SP: Spielberger State Anxiety Inventory (SSAI) plus Fear Questionnaire (FQ) items 3, 7, 9, 11, & 14h)– predose, 1h, 2h, 24h, 72h, 168h. Primary endpoint is change at 24h.[Primary endpoint is change at 24h.]

Secondary Outcome Measures

Name	Time	Method
Safety: vital signs (blood pressure, heart rate, O2 sats) [Screening and predose, 0:15, 0:30, 0:45, 1:00, 1:30, 2:00h and 24h post-dosing at each dose. <br>];Tolerability: reported adverse events. Most commonly patients report feeling woozy or dissociated 10-20mins post dosing. These can be assessed by self-report, or via use of the CADSS scale. <br>[Wooziness and dissociation will be assessed predose until 1h post dose. Adverse events will be recorded throughout the study.];Blood samples for plasma ketamine and metabolite concentrations, after each dose[predose, 15, 30, 60 and 120mins, and at 24h post each dose];Clinician Administered Dissociative Symptoms Scale (CADSS) [predose, 30 and 60mins post- each dose<br>];Montgomery Asberg Depression rating Scale (MADRS) [at screening, predose and 24h post- each dose<br>];Blood samples for plasma BDNF concentrations[Predose, 15, 30, 60 and 120mins, and at 24h post each dose]