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Acetazolamide for Treatment Resistant Schizophrenia

ConditionsSchizophreniaSchizo Affective Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVishwajit Nimgaonkar, MD PhD

About this trial

This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent.

Both genders, ages 18-55 years (older patients may not tolerate high ACZ dose).

PANSS total score > 60 and Score > 4 on one or more items of the 'positive' syndrome items (P1-P7), following treatment at therapeutic doses for 6 weeks with different APDs on 2 occasions.

Stable dose of antipsychotic drug (APD) for > 1 month, continued throughout the study.

Disqualifiers

Substance abuse in the past month/dependence past 6 months with the exception of methadone prescribed for opiate withdrawal.

History or current medical/neurological illnesses that may lead to unstable course, e.g., epilepsy.

Pregnancy.

Acetazolamide (ACZ) contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addison's disease/adrenal failure; chronic closed angle-closure glaucoma.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acetazolamide

    Drug

    ACZ 250 mg/day in gelatin capsules will be administered initially and increased over 7-10 days to 2g/day.

  • Placebo

    Drug

    Identical gelatin capsules will be prepared by filling with inert excipients.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: AcetazolamideActive comparator 1 intervention
Group B: PlaceboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in positive symptoms

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

Time frame
24 weeks

Secondary outcomes

1

Clinical Severity

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 30 Items, (minimum score = 7, maximum score = 210)

Time frame
24 weeks
2

Clinical Severity

Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

Time frame
24 weeks
3

Cognition

Trail Making Test (TMT) 86: This test estimates attention, working memory and executive function.

Time frame
24 weeks
4

Clinical Severity

"Clinical Global Impression - Severity" (CGI-S). The CGI-S is a 7-point scale that rates the severity of the patient's illness at the time of assessment. The minimum score is 1 and the maximum score is 100. Scores which are lower in value indicate greater severity of illness. Higher scores indicate less severe illness.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vishwajit Nimgaonkar, MD PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

Stanley Medical Research Institute

Collaborator

Source ClinicalTrials.gov
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